8891 · web viewsaes 4/15/05(4/15/05) motor & sensory neuropathy saes 4/15/05(4/15/05) card...

Condensed List of CALGB Audit Updates Revised 2/15/128461 act 6/22/84

26. 6/15/99 edit27. 8/15/99 edit28. 3/15/02 edit29. 6/15/02 Elig30. 7/15/02 CF31. 8/15/02 edit32. 2/15/04 CF

8921 SAE 9/15/06(9/15/06) liver failSAE 11/15/06(11/15/06) liver failSAE-a 10/15/07 Sweet’s syndSAE-a 1/15/08 pancreatitisSAE-a 3/15/08 chemical hepatitisSAEs-a 6/15/08 leucoclastic dermatitis

6/15/08 autoimmune pltsSAE-a 5/15/09 pancreatitisSAE-a 9/15/10 arterial thrombosis 1071465SAE-a/M 9/15/10 visceral art ischemia 1858271SAE-a/v 9/15/10 pneumonia 1900172 (11 SAEs)

9594 act 7/15/96 clos 9/1/081. 9/15/96 edit2. 6/15/97 Rx, Elig, CF3. 10/15/97 edit4. 1/15/98 Elig, CF5. 6/15/98 Elig.6. 9/15/98 CF7. 1/15/99 edit8. 4/15/99 edit9. 7/15/99 edit10. 8/15/99 CF11. 1/15/00 Elig12. 3/15/00 other13. 7/15/00 edit14 10/15/00 edit15. 1/15/01 edit16. 7/15/01 edit17. 9/15/02 edit18. 8/15/03 CF19. 7/15/04 Sc Δ, CF20. 10/15/04 edit21. 5/15/06 edit22. 11/15/11 edit

9665 act 5/15/961. 8/15/96 edit

2. 10/15/96 edit3. 1/15/97 edit4. 7/15/97 edit5. 11/15/97 edit6. 4/15/98 edit7. 2/15/99 edit, other8. 6/15/99 other-spec.update9. 6/15/02 edit

9687 act 5/31/97 clos 3/15/061. 6/15/97 edit2. 8/15/97 edit3. 10/15/97 Elig4. 11/15/97 edit5. 4/15/98 Elig6. 6/15/99 Elig, Rx, Sc7. 6/15/00 edit8. 10/15/02 Elig

9760 act 3/15/97 clos 1/15/111. 5/31/97 edit2. 9/15/97 Elig, CF3. 1/15/11 editPerm clos 1/15/11

9793 act 1/15/981. 7/15/98 Elig, CF2. 4/15/99 CF3. 10/15/99 Elig, CF4. 11/15/99 edit5. 3/15/01 Elig, CF6. 1/15/03 edit

9862 act 4/15/991. 12/15/99 edit2. 1/15/09 Sc , Elig,CF

10001 act 4/15/02 clos 4/30/101. 5/15/02 CF2. 7/15/02 CFSAE 1/15/03(1/10/03) CNS hemorrhageSAE 2/15/03(2/3/03) deathSAE 3/15/03(2/21/03) liver failureSAE 6/15/03(5/16/03) ↑ bili + lipase/rash/

desquamationSAE 7/15/03(6/30/03) esophageal fistula3. 12/15/03 Rx, Elig, CFSAEs 3/15/04(3/15/04) CNS hemorrhage/seizure/

pneumonitis/pul infilt3/15/04(3/15/04) hematuria

SAE 6/15/04(6/15/04) hemorrhage, renal calculiSAE 9/15/04(9/15/04) ↑ AST/ALT, autoimmune

hepatitisSAE 10/15/04(10/15/04) ↑ AST, ↑ ALT, auto-

immune hepatitis (FU)Act Ltr 11/15/04 (10/18/04)tumor of urogenital area4. 11/15/04 CFSAE 1/15/05(1/15/05) pneumonitisSAE 4/15/05(4/15/05) DIC, infection w/ ↓cts,

hemorrhage w/ ↓ pltsSAE 5/15/05(5/15/05) infectionSAEs 8/15/05(8/15/05) rash/desquamation

8/15/05(8/15/05) muscle weakness5. fb 8/15/05 Elig SAE 9/15/05 ↑ gluc, psychosisSAE 12/15/05(12/15/05) Merkel cell tumor FU

(Cont)

RRA (request for rapid amendment)-auditiors are to verify no patient was enrolled before IRB approvalCF = Consent form SAE – not listed on CALGB websiteElig = Eligibility changes to the protocol fb = full board review/nr =no review Rx = Treatment changes to the protocol er = expedited review/ sr = select reviewSc ∆ = Scientific changes to the protocol SAE-a = 1st letter of drug associatedSAE = Serious Adverse Event with SAEAct Ltr = Action Letter/AL Bold = IRB approval required

1

Condensed List of CALGB Audit Updates Revised 2/15/1210001 (Cont)

SAE 1/15/06(1/15/05) motor neuro, sensory neuro, cranial neuro, mood alter, leukoencephalapathy

SAE 2/15/06(2/15/06) urothelial caSAE 5/15/06(5/15/06) vasculitis

5/15/06(5/15/06) syncopeSAEs 8/15/06 (8/15/06) multiple sclerosis

8/15/06 (8/15/06) neuropathic painAct Ltr 8/16/06(8/1/06) severe CHF6. fb 10/15/06 CF, Act Ltr(L vent dysf)SAE 10/15/06(10/15/06) ↓ Ca, ↑ ALTSAE 11/15/06(11/15/06) depressionSAE 1/15/07(1/15/07) seizure, sudden deathSAEs-i 2/15/07(2/15/07) CNS hemorrhage

2/15/07(2/15/07) bone painSAE-i 3/15/07(3/15/07) colonic ulceration, GI

hem (rectal blding)SAE-i 4/15/07(4/15/07) bone pain - FUSAEs-i 5/15/07(5/15/07) LV dysfx, V tach

5/15/07(5/15/07) liver failSAE-i 7/15/07 bowel perf7. fb 9/15/07 drug 8.er 9/10/09 CF- pt notification(AL)HALT REGISTRATION9.nr 3/15/10 CAEPR updateClosure 4/30/1010. nr 6/15/10 CTCAE change(33 SAEs)

10002 act 5/15/02 clos 9/29/09Act Ltr 11/2/04 hepatitis, hep fail1. 12/15/04 CF2. fb 6/15/08 ppt, CFSAE-b/r 11/15/08 hemoptysis3. nr 6/15/10 edit, CTCAE change4.er 6/17/10 CF, CAEPR update (1 SAE)

10101 act 10/15/04 clos 12/15/06Act Ltr 11/2/04 hepatitis, hep fail1. 12/15/04 CF2. 8/15/05 other: AE reportSAE 9/15/05 hemorrhagic cystitis,

infect w/ BK virus, ↓ cts 3. 3/1/06 Rx, CFSAE 9/15/06(9/15/06) myelitisSAE 10/15/06(10/15/06) ↑ Crt, renal fail, dehyd, infect Memo 1/15/07 Rx SAEs 1/15/07(1/15/07) hemorrhagic cystitis

1/15/07(1/15/07) amoebic meningoencephalitis4. 3/15/07 Rx, CFSAE-a 3/15/07(3/15/07) renal failSAE-a 8/15/07 patchy nodular pul sSAEs-a 10/15/07 septic shock, renal fail,

met. acidosis10/15/07 dissem adenovirus infect10/15/07 syncope, mental status change

SAEs-a 1/15/08 transfusion-assoc GVHD,multi-organ fail/poss sepsis

1/15/08 infect mortalitySAE-a 6/15/08 opportunistic infect

(disseminated strongyloides)SAE-b/r 11/15/08 hemoptysisSAEs-a 4/15/10 L vent syst dysf (FU) 1402964

4/15/10 ↑ Glu, GI hem(FU) 1800034 (16 SAEs)

10102 act 6/15/03 clos 5/2/071. 8/15/03 edit2. 12/15/03 edit3. 8/15/05 CF,Sc , RxSAE 9/15/05 hemorrhagic cystitis,

infe w/ BK virus, ↓ ctsSAE 2/15/06(2/15/06) urothelial caSAEs 5/15/06(5/15/06) vasculitis

5/15/06(5/15/06) syncope SAEsSAEs 8/15/06 (8/15/06) multiple sclerosis

8/15/06 (8/15/06) neuropathic painAct Ltr 8/16/06(8/1/06) severe CHFSAE 9/15/06(9/15/06) myelitis4. 10/15/06 CF + Act Ltr (L vent sys dysf)SAE 10/15/06(10/15/06) ↑ Crt, renal fail, dehyd, infect

10/15/06(10/15/06) ↓ Ca, ↑ ALTSAE 11/15/06(11/15/06) depressionSAEs 1/15/07(1/15/07) seizure, sudden death

1/15/07(1/15/07) hemorrhagic cystitis1/15/07(1/15/07) amoebic meningoencephalitis

SAEs-i 2/15/07(2/15/07) CNS hemorrhage2/15/07(2/15/07) bone pain

SAE-a 3/15/07(3/15/07) renal failSAE-i 3/15/07(3/15/07) colonic ulceration, GI hemSAE-i 4/15/07(4/15/07) bone pain - FUSAEs-i 5/15/07(5/15/07) LV dysfx, V tach

5/15/07(5/15/07) liver failSAE-i 7/15/07 bowel perf5. fb 8/15/07 CFSAE-a 8/15/07 patchy nodular pul sSAEs-a 10/15/07 septic shock, renal fail,

met. acidosis10/15/07 disseminated adenovirus nfect10/15/07 syncope, mental status change

SAEs-a 1/15/08 transfusion-assoc GVHD,multi-organ fail/poss sepsis

1/15/08 infect mortalitySAE-a 6/15/08 opportunistic infect

(disseminated strongyloides)SAE-a 6/15/09 dyspnea, depression

6/15/09 L vent syst dysfx, pericard eff6/15/09 ↑glucose, GI hemorrhage,

ext pain, fractureSAEs-a 4/15/10 L vent syst dysf (FU) 1402964

4/15/10 ↑ Glu, GI hem(FU) 1800034 6.er 8/15/11 CTCAE version 4.0 (33 SAEs)

10105 act 12/15/03 clos 12/15/08SAEs 12/15/03(12/15/03) pneumonia, sepsis

12/15/03(12/15/03) unexplained death, poss CVA12/15/03(12/15/03) renal pain12/15/03(12/15/03) ataxia, depression, fatigue12/15/03(12/15/03) CV ischemia/CVA12/15/03(12/15/03) sinus bradycardia12/15/03(12/15/03) CV ischemia12/15/03(12/15/03) proteinuria

1. 2/15/04 editSAEs 2/15/04(2/15/04) temp cortical blindness/

speech disturbance/seizure2/15/04(2/15/04) ↑ ALT/ ↑ AST2/15/04(2/15/04) diarrhea2/15/04(2/15/04) severe exudative esophagitisSAE 3/15/04(3/15/04) reversible posterior

leukoencephalopathy SAE 4/15/04(4/15/04) gastritis/esophagitis

(Cont)

2

Condensed List of CALGB Audit Updates Revised 2/15/1210105 (Cont)

SAEs 4/15/04(4/15/04) gastritis/esophagitis4/15/04(4/15/04) coma4/15/04(4/15/04) hepatic (intratumoral) hem4/15/04(4/15/04) dehydration/malnutrition4/15/04(4/15/04) ↑ BP/ventricular bigeminy 4/15/04(4/15/04) sudden death4/15/04(4/15/04) encephalopathy

SAEs 5/15/04(5/15/04) dehydration/malnutrition(FU)5/15/04(5/15/04) cardiopul fail5/15/04(5/15/04) pul embolism

SAE 6/15/04(6/15/04) ↑ AST & ALTSAEs 7/15/04(7/15/04) methemoglobinemia

7/15/04(7/15/04) ↓ Na2. 8/15/04 Elig, CFSAE 8/15/04(8/15/04) ↑ INRSAEs 9/15/04(9/15/04) cardiac arrhy

9/15/04(9/15/04) polyarthralgia9/15/04(9/15/04) thrombocytopenia

SAEs 10/15/04(10/15/04) embolic stroke10/15/04(10/15/04) pernicious anemia10/15/04(10/15/04) possible cutaneous vasculitis,

fung skin infect, onychomycosisSAEs 12/15/04(12/15/04) rash

12/15/04(12/15/04) dizziness, ataxia12/15/04(12/15/04) GI bld – colon, atrial fib12/15/04(12/15/04) neurology – mental status12/15/04(12/15/04) ↑ triglycerides

SAE 1/15/05(1/15/05) hep hemorrhage3. 2/1/05 Rx,CFSAEs 2/15/05(2/15/05) reflux esophagitis

2/15/05(2/15/05) hepatic failure2/15/05(2/15/05) hypoxia, ↑ cardiac

troponin, atrial fibSAEs 3/15/05(3/15/05) CNS cerebrovas ischemia

3/15/05(3/15/05) thrombocytopenia3/15/05(3/15/05) GI hemorrhage – colon3/15/05(3/15/05) GI hemorrhage3/15/05(3/15/05) dizziness, syncope, N/V

SAE 6/15/05(6/15/05) anastomotic leakSAE 8/15/05(8/15/05) anemia, GI bldSAE 10/15/05(10/1505) hemorrhage CVASAE 12/15/05(12/15/05) resp failSAE 1/15/06(1/15/06) pul hemorrhageSAE 2/15/06(2/15/06) hemolytic anemiaSAE 4/15/06(4/15/06) lung abscessSAE 5/15/06(5/15/06) hemoptysis, pancreatitisSAE 9/15/06(9/15/06) FU (hemoptysis,

pancreatitis)4. fb 11/15/06 EligTemp Susp(low risk) 4/18/08Closure 12/15/085.er 6/15/11 CTCAE version 4.0 (54 SAEs)

10201 act 12/15/03 clos 10/20/06SAE 1/15/04(1/15/04) multi-organ failureSAE 2/15/04(2/15/04) renal failureSAE 3/15/04(3/15/04) resp fail/pneum/pul infiltSAE 9/15/04(9/15/04) systemic inflam resp synd1. 9/15/04 editSAE 10/15/04(10/15/04) pneumonitis, pul infilt, hypoxiaSAE 11/15/04(11/15/04) mucositis/stomatitis2. 11/15/04 ∆ dose modsSAEs 12/15/04(12/15/04) death, ↑ AST, ↑ ALT, ↑ CrtSAE 12/15/04(12/15/04) ↑ bili,, ↑ CrtSAE 3/15/05(3/15/05) PE, thrombosis/embolism

(Cont)10201 (Cont)

SAEs 4/15/05(4/15/05) motor & sensory neuropathySAEs 4/15/05(4/15/05) card ischemia/infarct, ↑ bili,

renal failure, ↓ mental staus4/15/05(4/15/05) card ischemia/infarct

SAE 5/15/05(5/15/05) infection3. 8/15/05 otherSAE 11/15/05(11/15/05) hypoxia, pneumonia, ARDS,

↓ BP, sepsis, sinus tach SAE 5/15/06(5/15/06) FUSAE 8/15/06 (8/15/06) torsade de pointes, v tach,

at fib, LV dysf, ↓wbc, bld infectSAE 10/15/06(10/15/06) aspirat, peritoneal cavity

hem, blad obst, somnolence,creat, abd distent, febrile ↓ cts, hypoxia, ileus, bone pain

Study results 12/8/06ppt + MD letter4. 10/15/07 edit(17 SAEs)

10303 act 1/15/05 clos 2/28/09SAE 4/15/05(4/15/05) DIC, infection w/ ↓cts,

hemorrhage w/ ↓ pltsSAE 5/15/05(5/15/05) infection 1. 7/15/05 editSAEs 8/15/05(8/15/05) rash/desquamation

8/15/05(8/15/05) muscle weaknessSAE 9/15/05(9/15/05) ↑ gluc, psychosisSAE 12/15/05(12/15/05) Merkel cell tumor FUSAE 1/15/06 motor/sensory/cranial neurop,

mood alter,leueukoencephalSAEs 5/15/06(5/15/06) vasculitis

5/15/06(5/15/06) syncopeSAEs 8/15/06 (8/15/06) multiple sclerosis

8/15/06 (8/15/06) neuropathic painSAE 10/15/06(10/15/06) ↓ Ca, ↑ ALT2. 11/15/06 Rx, CF, + Arm 3SAE 11/15/06(11/15/06) depressionClosure Arm #2 2/1/07SAE 1/15/07(1/15/07) seizure, sudden deathSAEs-i 2/15/07(2/15/07) CNS hemorrhage

2/15/07(2/15/07) bone painSAE-i 3/15/07(3/15/07) colonic ulceration, GI hem SAE-i 4/15/07(4/15/07) bone pain - FU3. er 5/15/07 editSAEs-i 5/15/07(5/15/07) LV dysfx, V tach

5/15/07(5/15/07) liver failSAE-i 7/15/07 bowel perf4. er 9/15/07 edit5. er 10/15/07 edit6. er 1/15/08 edit7. fb 4/15/08 CF, Rx, Sc∆8. er 7/15/08 CF9.er 2/19/09 CF(Action Letter)Closure 2/28/0910.er 4/17/09 CFSAE-d 7/15/09 conduct abn, asystoleSAE-d 8/15/09 cardiac ischemia11.er 9/17/09 CFSAE-d 10/15/09 asytole 151907412.er 5/15/10 CF, CAEPR update13. nr 6/15/10 other14.er 5/15/11 otherSAE-d 7/15/11 ↑ CPK(FU1) 142942015.er 12/15/11 Sc SAE-d 12/15/11 ↓K 146097716.e (RRA) 1/13/12 CF

3

Condensed List of CALGB Audit Updates Revised 2/15/12(26 SAEs)

10403 act 11/15/071. fb 6/2/08 CF, Rx2.er 7/15/08 CF,Rx,Elig3.fb 9/15/09 CF,Elig4.er 2/15/10 CF, Rx5.er 9/15/10 edit6.fb 11/1/10 Sc , Rx, CF, Elig7.fb 2/15/11 CF, AE rpt chg

10404 act 1/15/081. er 3/15/08 CFSAE-l 5/15/08 clonal evolution & prog from

MDS →RAEB-1SAEs-l 7/15/08 pseudotumor cerebri

7/15/08 meningoencephalitisSAE-l 8/15/08 psoriasisSAE-l 9/15/08 GISTSAE-b/l 9/15/08 sudden deathSAE-l 10/15/08 2nd malig, GIST (FU)SAE-b/r 11/15/08 hemoptysisSAE-l 11/15/08 sudden death SAE-l 12/15/08 sudden death (FU)SAE-b/l 2/15/09 sudden death (FU)2.er 3/15/09 Sc∆, CFSAE-b/l 3/15/09 SOB, death 1628411SAE-b/l 4/15/09 death 1673759SAE-l 4/15/09 leukoencephalopathy 10SAE-b/l 5/15/09 pneumonitis/pul infilt 1277486SAE-b/l 7/15/09 death (FU) 1673759SAE-l 8/15/09 lymphoblastic leuk 1203233SAE-l 9/15/09 ↑ Crt phos 1498428

9/15/09 laryn edema 1871314SAE-l 11/2/09 laryn edema (FU) 18713143.fb 11/2/09 CF, Sc∆, Rx 4.er 12/15/09 CFSAE-l 12/15/09 pneumonitis/pul infilt 1396794SAE-l 1/15/10 ↑ Crt phos (FU) 1498428SAE-l 3/15/10 pneumonitis/pul infilt

1396794 (FU)5.er 3/16/10 CF, CAEPR updateHALT REGISTRATIONSAE-b/l 4/15/10 pneumonitis, atrial fib1277486SAE-l 5/15/10 lymph leuk 1203233(FU)6.er 6/17/10 CF, CAEPR update7.er 8/15/10 CTCAE versionSAE-l/b 8/15/10 ONJ 1164386SAE-b/l 10/15/10 ONJ 1963940SAEs-l 10/15/10 meningitis 1528263

10/15/10 hemolysis 1740343SAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-l 1/15/11 hemolysis (FU)17403438.fb 2/15/11 dose mod/ancill Rx revSAE-l 3/15/11 hemolysis 1130645

3/15/11 cogn disturb 11684333/15/11 colitis 1518659

SAEs-l 4/15/11 ↑ creatinine 13561034/15/11 ↑ creatinine 13846824/15/11 meningitis(FU)15282634/15/11 viscer art ischemia 18018244/15/11 ↑ creatinine 1993413

9.er 5/15/11 CF, Action LetterSAE-b/l 5/15/11 ONJ 1963940SAEs-l 5/15/11 hemolysis 1094914

5/15/11 hemolysis(FU)1130645

(Cont)10404(Cont)

SAEs-l 5/15/11 cogn disturb(FU)11684335/15/11 neoplasm(FU) 13846825/15/11 ischemic colitis(FU)1518659

10.er 6/15/11 CF,eligSAE-l 7/15/11 cardiac arrest 1932440SAE-l/b 8/15/11 choroidal eff 1800822SAE-l 8/15/11 AML 1921183SAE-l/b 9/15/11 multi-organ fail 150693011.fb 9/30/11 CF, CAEPR updateSAEs-l/b 10/15/11 multi-organ fail(FU)1506930

10/15/11 choroidal effus(FU)1800822SAE-l 12/15/11 toxic optic neurop Rpt #lenal-11SAE-l 2/15/12 2nd ca Rpt #lenal-12(55 SAEs)

10501 act 1/15/08 clos 1/5/101. er 4/15/08 CFSAE-b/r 11/15/08 hemoptysis2. er 2/15/09 CF3.er 6/17/10 CF, CAEPR update4.fb 10/15/10 CF5.fb 9/15/11 CF(1 SAE)

10502 act 9/15/08 clos 2/26/10SAE-b/A 11/15/08 colitisSAE-b 1/15/09 ↓ K, ARDS, renal fail1. er 2/10/09 CF (Action Letter)SAE-b/l 2/15/09 sudden death (FU) SAE-b/A 2/15/09 septic shock, acidosis,

colitis (FU)SAE-b 2/15/09 renal fail, ↑bili, ↓ K,

ARDS(FU)SAE-b/l 3/15/09 SOB, deathSAE-b/A 3/15/09 infect, acidosis, colitis (FU2)SAE-b/l 4/15/09 deathSAE-b 4/15/09 ARDSSAE-b/l 7/15/09 death (FU)SAE-b 9/15/09 LVdysf 1887123SAE-b 12/1/09 ARDS 1073953

12/1/09 vent sys dysf 1850085SAE-b/v 12/1/09 sudden death 1495143Closure 2/26/10

SAEs-b 2/15/10 ARDS 16497992/15/10 resp fail 1705612

SAE-b/A 2/15/10 AV block 1658762SAE-b/v 3/15/10 multi-organ fail 1495143(FU)SAE-b 3/15/10 death 16173192.er 6/15/10 CF, CAEPR updateSAE-b/v 6/15/10 multi-organ fail (FU2)1495143SAE-b 6/15/10 ARDS, hypoxia1649799

6/15/10 hypoxia 1826902SAE-b 7/15/10 LV sys dysf (FU) 1850085

7/15/10 LV sys dysf (FU) 1887123 SAE-l/b 8/15/10 ONJ 1164386SAE-b 8/15/10 death 1617319 (FU)SAE-b/A 8/15/10 conduction abn 1658762SAE-b 9/15/10 resp fail(FU) 1705612 SAE-b/f 10/15/10 colitis 1358314SAE-b 12/1/10 ARDS 176221SAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-b 1/15/11 hypoxia(FU) 1826902SAE-b 4/15/11 ARDS(FU) 1762261 3.er 8/15/11 CTCAE version 4.0

4

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-l/b 8/15/11 choroidal eff 1800822SAE-b/f 8/15/11 esophagitis 1033338

(Cont)10502(Cont)

SAE-b 8/15/11 typhlitis 1959720SAE-l/b 9/15/11 multi-organ fail 1506930SAE-b/f 9/15/11 esophagitis(FU)1033338 SAEs-l/b 10/15/11 multi-organ fail(FU)1506930

10/15/11 choroidal effus(FU)1800822(40 SAEs)

10503 act 11/15/06 clos 7/30/10SAE 11/15/06(11/15/06) splenic infarct 12159251. er 9/15/07 CFSAE-d 10/15/07 thrombosis 1918667SAE-d 12/15/07 ↓ Na + 17746102. fb 5/15/08 CFSAE-d 8/15/08 pneumonitis, ↓O2 17213353.fb 9/15/08 CF, Rx4.er 7/17/09 CF- pt notification(AL)HALT REGISTRATION5.fb 3/15/10 CFSAE-d 3/15/10 endocarditis 16840566.er 6/15/10 CF, CAEPR update6.er 7/15/10 correctionSAE-d 7/15/10 endocarditis 1684056Perm clos 7/30/107.er 6/15/11 CTCAE version 4.08.er(RRA) 12/15/11 CF, CAEPR update(6 SAEs)

10602 act 11/15/06 clos 4/29/11Temp susp 9/5/071. fb 3/15/08 CF, Elig, Rx, Sc∆React 6/15/08SAEs-a 6/15/08 leucoclastic dermatitis

6/15/08 autoimmune ↓plts2. er 10/15/08 edit3.er 11/15/08 edit4.er 4/10/09 CFSAE-a 5/15/09 pancreatitisTemp susp 5/14/095.fb 8/15/09 CF, Sc∆,EligHALT REGISTRATIONReact 8/15/096. er 4/15/10 CF, CAEPR update7. er 4/15/10 CF, CAEPR updateSAE-a 9/15/10 arterial thrombosis 1071465SAE-a/M 9/15/10 visceral art ischemia 1858271SAE-a/v 9/15/10 pneumonia 1900172SAE-a 2/15/11 perf appendicitis

Rpt # azazcitidine-4Closure 4/29/11SAE-a 8/15/11 rhabdomyolysis

Rpt #azacitidine-58.er 12/15/11 CF, CAEPR update(8 SAEs)

10603 act 4/1/08 clos 10/15/11SAE-m 7/15/08 ↑ Ca ++

SAE-m 12/15/08 QTc prolongation1. fb 2/15/09 CF, Elig2.fb 4/1/09 CF, Rx3.er 12/1/09 CF, Rx4.er 12/15/10 Sc∆, Rx, CF5.er 5/15/11 CF6.nr 9/15/11 CTCAE version 4.07.er 11/15/11 edit

(2 SAEs)

10701 act 12/15/101.fb 1/15/11 Sc , Rx, CFSAE-d 3/15/11 sensory neuropathy 16282162.fb(RRA) 4/11/11 CF, AL, CAEPRSAE-d 5/15/11 sensory neurop(FU)1628216SAE-d 6/15/11 pul art ↑BP Rpt #dasat-33.fb 7/15/11 CFSAE-d 7/15/11 ↑ CPK(FU1) 1429420SAE-d 12/15/11 ↓K 14609774.fb 1/13/12 CF, Elig, CAEPR

10801 act 12/15/10 (distributed 3/15/11)1. 3/15/11 1st activation/CALGBSAE-d 3/15/11 sensory neuropathy 16282162.fb 4/11/11 CF, AL, CAEPRSAE-d 5/15/11 sensory neurop(FU)16282163.er 6/15/11 CFSAE-d 6/15/11 pul art ↑BP Rpt #dasat-3SAE-d 7/15/11 ↑ CPK(FU1) 14294204.fb 11/15/11 Sc , CFSAE-d 12/15/11 ↓K 14609775.fb 1/13/12 CF, Elig, CAEPR

11001 act 4/1/11SAE-s 4/15/11 sepsis 1546556SAE-s/e 5/15/11 death 1688406SAE-b/s 6/15/11 death 1850786SAE-s/e 7/15/11 GI perf 1688406SAE-s 7/15/11 card arrest(FU1)18073711.fb 8/15/11 CFSAE-b/s 8/15/11 death(FU) 1850786SAE-s/s 8/15/11 gastric perf 1279979SAE-s/s 9/15/11 gastric perf(FU) 12799792.er 11/15/11 CF, EligSAE-s 11/15/11 death 1224205SAE-s 12/15/11 death(FU) 1224205 (9 SAEs)

11002 act 11/16/111.er(RRA) 11/16/11 CF, CAEPR update

19808 act 11/15/00 clos 3/31/061. 3/15/01 edit2. 4/15/01 Rx3. 5/15/01 edit4. 6/15/01 edit5. 7/15/01 Rx, CF6. 3/15/02 edit7. 7/15/02 edit8. 6/15/03 Rx, CF9. 6/15/03 edit10. 10/1/03 Sc∆, Rx, CFSAE 10/15/03(9/29/03) multi-syst org fail/const sxs11. 6/15/05 CFSAE-I 1/15/08 thromb microangiopathy(2 SAEs)

20202 act 10/15/081.fb 3/15/11 Sc∆,elig,CF1.fb 4/15/11 correction (posted 3/22/11)2.fb 3/15/11 Sc∆,CF

20203 act 1/15/04

20206 act 1/15/04

5

Condensed List of CALGB Audit Updates Revised 2/15/12

20501 act 10/15/061.er 12/15/09 Sc∆

20502 act 5/15/06

20801 act 5/15/08

29801 act 12/15/98 clos 2/15/111. 5/15/00 edit2. 7/15/02 edit

30304 act 5/15/04 clos 2/15/06SAE 7/15/04(7/15/04) drug-induced coagulopathySAE 8/15/04(8/15/04) sudden death1. 9/15/04 Elig, CF2. 9/15/04 editSAE 11/15/04(11/15/04) sinus bradySAEs 12/15/04(12/15/04) dyspnea, at fib,infect w/o ↓cts

12/15/04(12/15/04) vent tachSAEs 4/15/05(4/15/05) arrhythmia- at fib

4/15/05(4/15/05) sudden deathSAE 7/15/05(7/15/05) sudden death3. 8/15/05 editSAE 9/15/05(9/15/05) card ischemia/infarctSAEs 10/15/05(10/15/05) card isch/infarct, lung hem,

↑ card trop I, atrial flutter SAE 12/15/05(12/15/05) ↓ BP-FU(11 SAEs)

30305 act 8/15/04 clos 2/12/081. 1/15/05 Elig2. 2/15/06 CF3. 10/15/08 edit

30306 act 12/15/04clos 4/10/061. 1/15/05 CFSAE 3/15/05(3/15/05) left retinal vein occlusion2. 4/15/05 CFSAEs 6/15/05(6/15/05) DIC

6/15/05(6/15/05) intestinal necrosis, perfReact 7/15/05SAEs 8/15/05(8/15/05) sudden death

8/15/05(8/15/05) resp fail, pul ↑ BP, hypoxia, ↑ card troponin T

3. 8/15/05 CF, RxSAE 9/15/05(9/15/05) resp fail, pul ↑ BPAct Ltr 10/13/05 GI perf SAEs 10/15/05(10/15/05) hypoxia

10/15/05(10/15/05) GI perf w/ abd pain10/15/05(10/15/05) hemoptysis

SAE 11/15/05(11/15/05) vent fib, L. vent sys dysf,card ischemia

SAEs 12/15/05(12/15/05) proteinura, ↑ BP, renal fail12/15/05(12/15/05) intracranial venous thromb,

cerebrovasc ischemia4. 1/15/06 Rx, CFSAEs 1/15/06(1/15/06) thrombotic microangiopathy,

proteinuriaSAEs 1/15/06(1/15/06) soft tiss necrosis/necrotizing

fasciitis, infect 1/15/06(1/15/06) abd hemorrhage, biliary perf,

necrotizing pancreatitisSAE 2/15/06(2/15/06) hemoptysisAct Ltr 4/3/06(3/27/06) PRESSAE 5/15/06(5/15/06) pul hemorrhage5. 5/15/06 Rx, CFSAEs 6/30/06(6/30/06) pul ↑ BP

6/30/06(6/30/06) bronchopul hemorrhage

6/30/06(6/30/06) perf appendix

(Cont)30306(Cont)

SAE 8/15/06(8/15/06) ↓ Ca, thromb microangiopathy, ↑ Crt, ↓ fibrinogen, renal fail, ↓ Na

SAEs 11/15/06 subq abcess11/15/06 stomach/colon perf w/peritonitis

SAE 12/15/06(12/15/06) intracranial hemorrhageSAE 1/15/07(1/15/07) thromb microangiopathy, HUSAEs-b 2/15/07(2/15/07) seizure

2/15/07(2/15/07) neutropenia, pneumoniaSAEs-b 4/15/07(4/15/07) metabolic acidosis,drowsiness

4/15/07(4/15/07) tracheal inj (lacerat or infarct)4/15/07(4/15/07) cellulitis4/15/07(4/15/07) tracheoesophageal fistula

SAEs-b 6/15/07 tracheitis FU6/15/07 hepatic cirrhosis

SAEs-b 7/15/07 CSF leak, intracranial ↓ BP7/15/07 soft tiss necrosis of neck

SAEs-b 8/15/07 hydropneumothoraxSAE-b 9/15/07 death, ↓ wbc, ↓ plts,

metabolic acidosisSAE-b/o 11/15/07 lower GI hem, rectal leak,

rectal perf, pelvic abscessSAE-b 11/15/07 encephalitisSAE-b 12/15/07 hepatic cirrhosis

12/15/07 ITPSAE-b/s 12/15/07 card ischemia/infarctSAEs-b 1/15/08 ↑ Na+

1/15/08 GI perf1/15/08 leukoencephalopathy

SAE-b/e 1/15/08 death(removed)SAEs-b 2/15/08 ↑ Na++

2/15/08 acute renal failureSAE-b/s 2/15/08 lact acidosis, bowel ischemia

2/15/08 hemolysisSAEs-b 3/15/08 tracheomalacia

3/15/08 tumor ulceration in breast3/15/08 CNS tumor necrosis

SAE-b/C 3/15/08 leucocytoclastic angiitisSAE-b/s 3/15/08 hemolysis (Revised)SAEs-b 5/15/08 necrotizing fasciitis

5/15/08 thrombocytopenia5/15/08 cognitive & MRI∆

SAE-b/c 5/15/08 osteonecrosis of spineSAEs-b 6/15/08 lung collapse, tumor necrosis,

bronchopleural fistula6/15/08 tumor necrosis, pul

hem, pneumothorax6/15/08 renal fail, proteinuria,

↓ANC,↓plts SAE-b/c 6/15/08 osteonecrosis of spineSAEs-b 8/15/08 hydrocephalus

8/15/08 radiation retinopathySAEs-b 9/15/08 ↓plts

9/15/08 non-infectious ext otitis w/tympanic perf

SAEs-b/e 9/15/08 blurred vision9/15/08 MDS

SAE-b/v 10/15/08 sudden deathSAEs-b 10/15/08 sudden death

10/15/08 non-infectious ext otitis w/tympanic perf-FU

SAE-b 10/15/08 sudden deathSAE-s/b 10/15/08 sudden death

6

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b 11/15/08 ARDS

11/15/08 sudden death

(Cont)30306(Cont)

SAEs-b 11/15/08 sudden death11/15/08 fat necrosis11/15/08 cerebellar synd

SAE-b/e 11/15/08 pneumomediastinumSAE-b/r 11/15/08 hemoptysisSAE-b/o 12/15/08 L vent systolic dysfSAEs-b/t 12/15/08 L vent dysf

12/15/08 ↓Mg 12/15/08 death

SAEs-b 12/15/08 ARDS(FU)12/15/08 PE12/15/08 rash, lower ext pain12/15/08 MDS12/15/08 death from unk cause

SAE-b/s 12/15/08 intracerebral hemorrhageSAE-b/e 12/15/08 pneumomediastium(FU)SAE-b/t 1/15/09 L vent dysf(FU)SAEs-b 1/15/09 pul infilt

1/15/09 sudden death(FU)1/15/09 fat necrosis(FU)1/15/09 myalgia, rash, lethargy(FU)1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm arterial/R atrial thrombi (FU)2/15/09 vertigo2/15/09 BBB

SAE-b/t 2/15/09 ↓Mg (FU)SAEs-b/t 3/15/09 dehydration

3/15/09 PRES3/15/09 death (FU)

SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓BP (FU)SAE-b 4/15/09 pneumonitis/pul infilt,

pericard eff (FU)4/15/09 card troponin I, card

isch/infarctSAE-b/t 4/15/09 death (FU2)

4/15/09 ONJSAE-b/t 5/15/09 dehydration(FU)SAE-b/l 5/15/09 pneumonitis/pul infilt, atrial fibSAE-b 5/15/09 sudden death

5/15/09 pneumothoraxSAEs-b 6/15/09 ↓plts

6/15/09 peritoneal cavity infect, GI perf, GI abscess

6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis

SAEs-b 6/15/09 cardiopul arrest6/15/09 esophageal fistula6/15/09 CNS hemorrhage, seizure6/15/09 PE, rectal infect

SAEs-b 6/15/09 leukoencephalopathy w/seizure, ↑ Crt

6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis

SAE-b/o 6/15/09 allergic reaction (FU)SAEs-b/t 6/15/09 pneumonitis/pulm infilt

6/15/09 sudden deathSAEs-b 7/15/09 ↓plts – poss ITP (FU)

7/15/09 ischemic colitis7/15/09 esophageal fistula (FU)

7/15/09 N/V, HA, dizziness, confus, dysphagia, subdur hematoma,acute CNS bleed

(Cont)30306(Cont)

SAEs-b 7/15/09 spontaneous pneumothorax(FU7/15/09 renal fail, req dialysis (FU)7/15/09 ↑ card troponin, ↑ CPK,

card ischemia/infarct(FU)SAEs-b/t 7/15/09 RPLS (FU)

7/15/09 deathSAEs-b 8/15/09 CNS hemorrhage(FU)

8/15/09 opportunistic infect assoc w/lymphopenia(FU)

SAEs-b 8/15/09 sudden death(FU)8/15/09 pul hem, pneumonitis (FU)

SAEs-b/t 8/15/09 death(FU)8/15/09 ONJ(FU)

SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAEs-b 9/15/09 CNS hem(FU) 1687519

9/15/09 seizures(FU) 18335689/15/09 hydronephrosis 1836781

SAE-b 10/15/09 esoph strict 1279067SAEs-b 10/15/09 c pul arrest(FU) 1333814

10/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915

SAEs-b/t 10/15/09 dehydration 171030910/15/09 sudden death(FU) 1718620

SAE-b/i 11/2/09 death 1857033SAE-b 12/1/09 colitis(FU) 1202538SAE-b/t 12/1/09 pneu(FU) 1392926SAE-b/s 12/1/09 microangiopathy 1613977

12/1/09 microangiopathy 131252712/1/09 microangiopathy 147408112/1/09 microangiopathy 1395393

SAEs-b 12/15/09 sudden death 118469412/15/09 GI perf(FU) 119244012/15/09 confusion 1206408

SAE-b/i 12/15/09 death (FU) 1857033SAE-b/s 12/15/09 dis prog 1939558SAE-b/t 1/15/10 fatigue 1448075SAE-b/s 1/15/10 ↓ BP 1329500SAEs-b 2/15/10 sudden death 1070874

2/15/10 esoph strict(FU) 12790672/15/10 death 18588572/15/10 hemoptysis 1901777

SAE-b 3/15/10 death 1900407SAEs-b 4/15/10 atrial fib 1003452

4/15/10 SBO 12365024/15/10 colitis 12952534/15/10 death 13666724/15/10 asystole (FU) 14491904/15/10 ileus,SBO, ↓Na 1544184

SAE-b/l 4/15/10 pneumonitis 1277486SAE-b/t 4/15/10 dehydration 1561869

4/15/10 rectal pain, anal fistula 16712224/15/10 dehydration (FU) 1710309

SAE-b/s 4/15/10 RPLS, ↑ BP 1706912SAE-b/sun 4/15/10 disease prog (FU) 1939558 SAEs-b/t 5/15/10 renal fail 1220746

5/15/10 LV sys dysf 12495185/15/10 dehydration 16704735/15/10 rectal hem 1746507

SAE-b/s 5/15/10 MI 1329500SAEs-b 6/15/10 cerebral edema 1138043

6/15/10 sudden death( FU)1184694 6/15/10 confusion (FU)1206408

7

Condensed List of CALGB Audit Updates Revised 2/15/126/15/10 death (FU) 1366672

SAE-b/t 6/15/10 anal ulcer 1367114

(Cont)30306(Cont)

SAEs-b 7/15/10 sudden death 11903667/15/10 cere ischemia(FU)19017777/15/10 vertigo (FU) 1996104

SAEs-b/t 7/15/10 pneumonitis (FU)1249518 7/15/10 cogn disturb (FU)14480757/15/10 infection 1981052

SAE-b/i 8/15/10 cholecystitis 1035078SAE-b 8/15/10 sudden death (FU)1070874

8/15/10 sudden death(FU) 11903668/15/10 colitis (FU) 1295253

SAE-b/t 8/15/10 rectal pain(FU)1671222SAE-b 9/15/10 cerebral edema(FU)1138043

9/15/10 death(FU) 1900497SAE-b/s 9/15/10 RPLS(FU) 1706912 SAEs-b/t 10/15/10 renal fail(FU) 1220746

10/15/10 anal ulcer(FU) 136711410/15/10 dehydration (FU) 156186910/15/10 dehydration(FU) 167047310/15/10 rectal bleeding (FU) 1746507

SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU)1236502

SAE-b/l 10/15/10 ONJ 1963940SAE-b/i 11/1/10 cholecystitis(FU) 1035078SAE-b 11/1/10 cardiac arrest(FU)1544184

11/1/10 sudden death 1584360SAE-b 12/1/10 osteonecrosis 1470711SAEs-b 1/15/11 atrial fib (FU) 1003452

1/15/11 colitis (FU2) 12952531/15/11 LV systolic dysfx 13833881/15/11 sm bowel perf(FU) 14488481/15/11 sudden death (FU2) 14491901/15/11 ARDS 15137261/15/11 sudden death (FU) 15843601/15/11 cellulitis 1852653

SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 1075201SAEs-b 3/15/11 atrial fib(FU2) 1003452

3/15/11 pneumonitis/pulm infilt14837493/15/11 tinnitus 1897814

SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts (FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU) 1075201 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamp 13574335/15/11 sudden death(FU) 14429535/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU)16942925/15/11 sudden death 1706673

5/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32

(Cont)30306(Cont)

SAEs-b/t 5/15/11 anal fissure 1345682 5/15/11 LV systolic dysf 1792675

SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940SAE-d 5/15/11 sensory neurop(FU)1628216SAEs-b 6/15/11 sudden death 1173562

6/15/11 pneumonitis(FU) 14837496/15/11 necrotizing fasciitis 16532476/15/11 sudden death(FU) 17066736/15/11 ARDS 1727423

SAE-b/t 6/15/11 LV systolic dysf(FU)1792675 SAE-b/s 6/15/11 death 1850786SAEs-b 7/15/11 acute kidney inj 1226625

7/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 13352677/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)16532477/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 17611917/15/11 death 1793638

SAEs-b/t 7/15/11 anal fissure(FU1) 13456827/15/11 resp fail 1860656

SAE-b/v 7/15/11 syncope 1714540SAEs-b 8/15/11 pulm hem 1150431

8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synod 12582398/15/11 cardiac arrest 12687588/15/11 ascites 14716528/15/11 resp fail(FU) 16456508/15/11 pneumonitis 16751888/15/11 death(FU) 1793638

SAE-b/s 8/15/11 death(FU) 1850786SAE-b/i 8/15/11 bronchial hem 1868649SAEs-b 9/15/11 pulm hem(FU)1150431

9/15/11 cerebellar synd(FU)12582399/15/11 cardiac arrest(FU)1268758

SAEs-b 10/15/11 perirectal abscess 103725810/15/11 AML 117814310/15/11 cellulitis 1874144

SAE-b/i 10/15/11 ↑BP 1059673SAEs-b/i 11/15/11 ↑BP(FU) 1059673 SAE-b 11/15/11 AML(FU) 1178143

11/15/11 ataxia Rpt#bev-3411/15/11 leukoenceph Rpt#bev-34

SAE-b 12/15/11 optic neurop 1301534SAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955

SAE-b 2/15/12 hydrocephalus 1512246(306 SAEs)

30402 act 7/15/05 clos 9/28/06SAEs 8/15/05(8/15/05) stiff neck, HA

8/15/05(8/15/05) confus, photophobia,ARDS, acute exacerb atrial fib

8/15/05(8/15/05) colitisSAEs 9/15/05(9/15/05) pul hem

9/15/05(9/15/05) CHF, exacerbation of COPD, pancytopenia, death d/t massive liver failure

9/15/05(9/15/05) wound healing by 20 intention9/15/05(9/15/05) card ischemia/infarct

8

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs 9/15/05(9/15/05) CNS hemorrhage, gluc, febrile ↓ cts,↑ BP

9/15/05(9/15/05) acute hypersensitiv react(FU)SAEs 9/15/05(9/15/05) pul infilt

(Cont)30402(Cont)

SAE 10/15/05(10/15/05) card failureSAEs 10/15/05(10/15/05) hypotensive shock

10/15/05(10/15/05) vent arrhythmiaSAE 11/15/05(11/15/05) aller react, anaphylactic shkSAEs 12/15/05(12/15/05)↓ BP

12/15/05(12/15/05) CV collapseSAEs 2/15/06(2/15/06) acute renal fail

2/15/06(2/15/06) hemoptysis,epistaxis, pul hem2/15/06(2/15/06) death,diarrhea,card fail,

renal fail2/15/06(2/15/06) interstitial nephritis, elect

abn(↓ K & ↓Mg)2/15/06(2/15/06) acute lung edema

SAEs 2/15/06(2/15/06) fatal colitis w/ necrosis of ileum 20 to mesenteric infarct

SAEs 3/15/06(3/15/06) ax venous thrombosis, LE purpura & vasculitis

SAEs 3/15/06(3/15/06) ↑ bili, cholangitis, cholestasis3/15/06(3/15/06) at fib, ↓ BP, coagulopathy

SAEs 3/15/06(3/15/06) pul hemorrhage, post-obstruct, pneumonia

SAE 3/15/06(3 /15/06) pancolitisSAEs 4/15/06(4/15/06) interstitial pneumonitis

4/15/06(4/15/06) diarrhea, sepsis synd4/15/06(4/15/06) ↓ Ca, neutropenic sepsis4/15/06(4/15/06) perf bowel4/15/06(4/15/06) GI perf-colon

SAEs 6/30/06(6/30/06) interstitial pneumonitis6/30/06(6/30/06) hearing loss6/30/06(6/30/06) infected pneumatocele

SAE 6/30/06(6/30/06) resp fail, interstitial pneumonitisSAE 7/15/06(7/15/06) CNS hemorrageSAE 10/15/06(10/15/06) ruptured ovarian cystSAEs-c 12/15/06 bile duct stenosis

12/15/06 GI necrosis, colon perfSAE-c 5/15/07 hemiparesisSAE-c 8/15/07 duodenal ulcer w/hemSAE-c 9/15/07 GI perfSAE-c 12/15/07 hyperosmolar nonketotic comaSAEs-c 1/15/08 suspected epidermal necrolysis

1/15/08 leucocytoclastic vasculitisSAEs-c 2/15/08 suspected epidermal necrolysis

2/15/08 hepatic cytolysisSAE-b/c 3/15/08 leucocytoclastic angiitisSAEs-c 4/15/08 bronchiolitis obliterans,

resp insuff, fever4/15/08 gastric perf4/15/08 Quincke’s edema

SAE-b/c 5/15/08 osteonecrosis of spineSAE-c 5/15/08 sepsis, pancytopenia,

metabolic acidosisSAE-b/c 6/15/08 osteonecrosis of spineSAEs-c 6/15/08 esophageal obst, esophagitis

6/15/08 airway obstSAE-c 7/15/08 ingrown eyelashesSAE-b 7/15/08 prolonged OTc interval,

cardiac troponinSAEs-c 8/15/08 phimosis

8/15/08 nephropathy w/hematuria, acute tubular injury, renal fail

8/15/08 ventricular arrhythmiaSAEs-c 9/15/08 esophagitis

9/15/08 portal vein thrombosis, splenomegaly, focal nodular hyperplasia

SAE-c 9/15/08 cataract(Cont)

30402(Cont)SAE-c 10/15/08 bronch hemorrhageSAEs-c 11/15/08 dry eye synd

11/15/08 allergic alveolitisSAE-b/A 11/15/08 colitisSAEs-c 12/15/08 nephropathy w/hematuria,

acute tubular injury, renal fail(FU)

12/15/08 dry eye synd(FU)12/15/08 leukocytoclastic vasculitis12/15/08 brachial artery thrombosis12/15/08 pericardial eff

SAE-c 12/15/08 hypovolemic shk, lactic acidosisSAE-b 1/15/09 ↓K, ARDS, renal failSAE-c 1/15/09 card failSAEs-c 2/15/09 ileus

2/15/09 cerebral hemSAEs-c 2/15/09 CHF

2/15/09 tumor hemSAE-b/l 2/15/09 sudden death (FU)SAE-b/A 2/15/09 septic shk, acidosis, colitis (FU)SAE-b 2/15/09 renal fail, ↑bili,↓K, ARDS (FU)SAE-c 4/15/09 anastomotic insuffSAE-b 4/15/09 ARDSSAE-c 5/15/09 erythema multiforme

5/15/09 cerebral hemorrhage5/15/09 R vent fail, pleural eff

SAE-c 6/15/09 necrotizing fasciitisSAE-b/l 7/15/09 death (FU)SAE-c 8/15/09 laryngeal necrosis

8/15/09 GE hem, mucosal inflameSAE-c 10/15/09 gastric hem 126

10/15/09 nec vasculitis 12710/15/09 pulm fibrosis 128

SAE-c 11/2/09 GI perf cetux-129SAE-b 12/1/09 ARDS 1073953

12/1/09 vent sys dysf 1850085SAE-b/v 12/1/09 sudden death 1495143SAE-e/c 3/15/10 asteatotic eczema(FU)

1670060SAE-b 7/15/10 LV dysf(FU) 1850085

7/15/10 LV dysf(FU) 1887123SAE-l/b 8/15/10 ONJ 1164386SAE-b/A 8/15/10 conduction abn 1658762SAE-b/f 10/15/10 colitis 1358314SAE-b 12/1/10 ARDS 176221(105 SAEs)

30406 act 8/15/05 clos 4/29/09SAE 9/15/05(9/15/05) skin necrosisSAE 10/15/05(10/15/05) renal failSAE 11/15/05(11/15/05) ↓ wbc, ↓ plts, dyspneaSAE 12/15/05(12/15/05) pneumonitis/pul infiltSAE 1/15/06(1/15/06) thrombotic microangiopathy,

proteinuriaSAE 2/15/06(2/15/06) esophageal fistulaSAE 4/15/06(4/15/06) dactylitis,palmar plantar-

like syndSAE 1/15/07(1/15/07) necrotic skin ulceration1. er 3/15/07 editSAE-b/e 1/15/08 death(removed)SAE-s/e 1/15/08 colon perf2. er 6/15/08 ∆ppt

9

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b/e 9/15/08 blurred vision

9/15/08 MDS3.er 10/24/08 CF, EligSAE-b/e 11/15/08 pneumomediastinum

(Cont)30406(Cont)

SAE-b/e 12/15/08 pneumomediastiumSAE-e/t 4/15/09 CSF leak, wound comp, deathSAE-e 4/15/09 renal failClosure 4/29/09SAE-e 5/15/09 pericardial eff4. er 5/27/09 CF- pt notification(AL)SAE-e/t 7/15/09 cerebrospinal fluid leak,

wound infectSAEs-e 7/15/09 diarrhea, renal fail (FU)

7/15/09 pericardial effSAE-e 9/15/09 edema 1670060SAE-e 2/15/10 ↑glycemia 1727021SAE-e/i 2/15/10 ↓ BP 1559936SAE-e/c 3/15/10 asteatotic eczema (FU)

1670060SAE-e/i 4/15/10 card ischemia 12031665.sr 5/15/10 editSAE-e 5/15/10 ↑gly 1727021 FUSAEs-e/i 7/15/10 cardiac ischemia 1203166

7/15/10 hypoxia 13980667/15/10 ↓ BP 1559936

SAE-e 9/15/10 resp fail 1531241SAEs-e/i 1/15/11 pneumonitis (FU)1398066

1/15/11 pneumonia 1743915SAE-e 1/15/11 ARDS(FU) 15312416.er 12/1/10 editSAE-e/G 3/15/11 ↓plts 1392174SAE-b 4/15/11 ARDS(FU) 1762261 SAE-e 4/15/11 ↓plts (FU) 1392174SAE-s/e 5/15/11 death 1688406SAE-e/A 5/15/11 gastric hem 1242384SAE-e/i 5/15/11 pneumonia(FU)1743915SAE-e/A 6/15/11 gastric hem(FU)1242384

SAE-s/e 7/15/11 GI perf 1688406SAE-e/A 7/15/11 hypoxia 1276865SAE-e/A 8/15/11 pneumonitis(FU) 1276865SAE-e/M 8/15/11 UTI 19643237.er 9/15/11 CTCAE version 4.0SAE-e/A 11/15/11 ↑CPK 1745420SAE-e 12/15/11 ↑CPK(FU) 1745420(44 SAEs)

30407 act 9/15/05 clos 1/2/08SAEs 9/15/05(9/15/05) pul hem

9/15/05(9/15/05) pul infilt9/15/05(9/15/05) CHF, exacerbation of COPD,

pancytopenia, death d/t liver fail9/15/05(9/15/05) wound healing by 20 intention

SAEs 10/15/05(10/15/05) card failure 10/15/05(10/15/05) hypotensive shock

10/15/05(10/15/05) vent arrhythmiaSAE 11/15/05(11/15/05) allergic react, anaphyl shockSAEs 12/15/05(12/15/05) ↓ BP

12/15/05(12/15/05) CV collapse1. 1/15/06 Elig, CFSAEs 2/15/06(2/15/06) acute renal fail

2/15/06(2/15/06) hemoptysis,epistaxis, pul hemSAEs 2/15/06(2/15/06) death,diarrhea,card fail,

renal failSAEs 2/15/06(2/15/06) interstitial nephritis, elect

abn(↓ K & ↓Mg)SAEs 2/15/06(2/15/06) acute lung edema

2/15/06(2/15/06) fatal colitis w/ necrosis of ileum 20 to mesenteric infarct

(Cont)30407(Cont)

SAE 3/15/06(3/15/06) ax venous thrombosis, LE purpura & vasculitis

SAEs 3/15/06(3/15/06) ↑ bili, cholangitis, cholestasis3/15/06(3 /15/06) at fib, ↓ BP, coagulopathy

SAEs 3/15/06(3/15/06) pancolitis3/15/06(3/15/06) pul hemo, post-obstruct,

pneumoniaSAEs 4/15/06(4/15/06) interstitial pneumonitis

4/15/06(4/15/06) diarrhea, sepsis synd4/15/06(4/15/06) ↓ Ca, neutropenic sepsis4/15/06(4/15/06) perf bowel4/15/06(4/15/06) GI perf-colon

2. fb 5/15/06 RxSAEs 6/30/06(6/30/06) interstitial pneumonitis

6/30/06(6/30/06) hearing loss6/30/06(6/30/06) infected pneumatocele6/30/06(6/30/06) resp fail, interstit pneumonitis

SAE 7/15/06(7/15/06) CNS hemSAE 10/15/06(10/15/06) ruptured ovarian cyst3. 12/15/06 Rx, CFSAEs 12/15/06(12/15/06) bile duct stenosis

12/15/06(12/15/06) GI necrosis, colon perfSAE-c 5/15/07(5/15/07) hemiparesisSAE-c 8/15/07 duodenal ulcer w/hemorrhageSAE-c 9/15/07 GI perfSAE-c 12/15/07 hyperosmolar nonketotic comaSAEs-c 1/15/08 suspected epiderm necrolysis

1/15/08 leucocytoclastic vasculitisSAEs-c 2/15/08 suspected epiderm necrolysis

2/15/08 hepatic cytolysisSAE-b/c 3/15/08 leucocytoclastic angiitisSAEs-c 4/15/08 bronchiolitis obliterans,

resp insuff, fever4/15/08 gastric perf4/15/08 Quincke’s edema



6/15/08 airway obstSAE-c 7/15/08 ingrown eyelashesSAEs-c 8/15/08 phimosis

8/15/08 nephropathy w/hematuria, acute tubular injury, renal failure

SAE-c 8/15/08 ventricular arrhythmiaSAEs-c 9/15/08 esophagitis

9/15/08 portal vein thrombosis, splenomegaly, focal nodular hyperplasia

SAE-c 9/15/08 cataractSAE-c 10/15/08 bronch hemorrhageSAEs-c 11/15/08 dry eye synd

11/15/08 allergic alveolitisSAEs-c 12/15/08 nephropathy w/hematuria, acute

tubular injury, renal fail(FU)12/15/08 dry eye synd(FU)12/15/08 leukocytoclastic vasculitis 12/15/08 brachial artery thrombosis

SAEs-c 12/15/08 pericardial eff12/15/08 hypovol shock, lactic acidosis

SAE-c 1/15/09 card fail

10

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-c 2/15/09 ileus

2/15/09 cerebral hem2/15/09 CHF

SAE-c 2/15/09 tumor hem (Cont)

30407(Cont)SAE-c 4/15/09 anastomotic insuffSAE-c 5/15/09 erythema multiforme

5/15/09 cerebral hem5/15/09 R vent fail, pleural eff

SAE-c 6/15/09 necrotizing fasciitisSAE-c 8/15/09 laryngeal necrosis

8/15/09 GE hem, mucosal inflameSAE-c 10/15/09 gastric hem 126


SAE-c 11/2/09 GI perf 1294.er 2/15/10 Sc ∆SAE-e/c 3/15/10 asteatotic eczema (FU)

1670060SAE-c 2/15/11 death Rpt #cetux – 130

2/15/11 edema Rpt #cetux – 131SAE-c 2/15/11 interstitial pneumonitis

Rpt #cetux – 1322/15/11 peripheral arterial thrombosis

Rpt #cetux – 133SAE-c 3/15/11 cardiac arrest

Rpt #cetux-1343/15/11 pneumatosis intestinalis

Rpt #cetux-135SAE-c 4/15/11 perf divertic

Rpt #cetux-136SAEs-c 5/15/11 neutropenia 1409011

5/15/11 acute renal failRpt #cetux-1375/15/11 cardiopul arrest Rpt #cetux-138

SAEs-c 7/15/11 acute kidney injury Rpt #cetux-1397/15/11 TIA Rpt #cetux-1407/15/11 asterixis, death Rpt #cetux-141

SAE-c 8/15/11 septic shock Rpt #cetux-1428/15/11 laryngeal hem Rpt #cetux-143

SAE-c 10/15/11 stasis derm Rpt #cetux-144SAE-c 11/15/11 cerebral infarct Rpt #cetux-145

11/15/11 ↓mobility Rpt #cetux-146SAE-c 12/15/11 cranial hem Rpt #cetux-147(104 SAEs)

30501 act 7/15/05 clos 10/1/071. 1/15/06 CF2. 10/15/06 CF (9925)

30504 act 3/15/07 clos 12/13/11SAE-s 4/15/07(4/15/07) rhabdomyolosisSAEs-s 6/15/07 myocarditis, hep insuff,

encephalopathy, pneumonia, renal insuff

6/15/07 diverticular perf1. er 7/15/07 CFSAEs-s 7/15/07 soft tiss necrosis of neck

7/15/07 LV sys dysfx7/15/07 thrombotic microangiopathy

SAEs-s 8/15/07 rhabdomyolysis w/renal fail8/15/07 LV sys dysf

SAE-s 9/15/07 thrombotic microangiopathy,GI perf

Susp 9/26/07SAE-s 10/15/07 dysphagia,

tracheoesophageal fistulaSAE-s 12/15/07 LV systolic & diastolic

dysf, card ischemiaSAEs-b/s 2/15/08 lactic acidosis, bowel ischemia

2/15/08 hemolysis

(Cont)30504 (Cont)

SAEs-s 2/15/08 hepatic failure2/15/08 GI stoma hem

SAE-s/s 2/15/08 cerebrovascular ischemia2.fb 2/15/08 CF- pt notification(AL)Reactivation 2/15/08SAE-b/c 3/15/08 hemolysis (Revised)SAEs-s 4/15/08 cellulitis

4/15/08 L vent systolic dysfSAE-s/s 4/15/08 renal failSAE-s 5/15/08 liver failSAE-s 6/15/08 poss freq of fistulasSAE-s 7/15/08 rectal fistulaSAE-s/s 8/15/08 stomach hemSAE-s 8/15/08 GI fistula, hypokalemiaSAEs-s 10/15/08 sys cap leak synod

10/15/08 hrt fail-FUReact 11/15/083.fb 11/15/08 Rx, Sc ∆, CF SAE-s/s 2/15/09 thrombosis, chest pain4.er 2/25/09 CF(Action Letter)SAE-s/s 3/15/09 thrombosis PE (FU)SAE-s 4/15/09 pul hemorrhageSAE-s/s 4/15/09 proteinuria, ↓ hgb5.fb 4/17/09 Rx, Sc ∆, CFSAE-s 5/15/09 necrotizing pancreatitisSAE-s 7/15/09 muscle weakness, ↓pltsSAE-b/s 8/15/09 thrombotic microangiopathySAEs-s 8/15/09 pul hem(FU)

8/15/09 PE6.er 9/21/09 CFHALT REGISTRATIONSAE-b/s 12/1/09 microangiopathy 1613977


SAEs-s 12/1/09 weakness(FU) 149169412/1/09 GI hem 1920386

SAE-s/s 12/1/09 proteinuria(FU)1704399SAE-b/s 12/15/09 dis prog 1939558SAE-b/s 1/15/10 ↓ BP 1329500 SAE-s 1/15/10 PE (FU) 1168449SAE-s/s 2/15/10 PE 1222406SAE-s 2/15/10 septic shock, pancolitis

2009299939/sunit-77.er 4/15/10 CF, CAEPR updateSAE-b/s 4/15/10 disease prog (FU) 1939558 SAE-s 4/15/10 laryngeal edema 1274440

4/15/10 dilated intest loops 17333784/15/10 CV ischemia 1788898

SAE-b/s 5/15/10 MI 1329500SAE-s/s 5/15/10 PE(FU) 1222406 SAE-s 6/15/10 dilated intest loops(FU) 1733378 SAE-s 7/15/10 cereb ischemia 1788898

7/15/10 hypoxia 1842265 SAE-s 9/15/10 laryngeal edema(FU)1274440

8.er 10/6/10 CF, CAEPR updateSAE-s 10/15/10 CNS hem (FU)1842265 SAE-s 11/1/10 lung hem 1272083 SAE-s/c 12/1/10 pneumonitis 1226140 9.er 12/15/10 CF10.fb 1/15/11 CFSAE-s/c 1/15/11 pneumonitis (FU) 1226140

11

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-s 1/15/11 thrombosis 1541780

1/15/11 pul ↑BP sunit-8SAE-s 2/15/11 MDS 1423773

(Cont)30504 (Cont)

SAE-s 3/15/11 pheochromocytomaRpt #sunit-9

SAE-s 4/15/11 death 185662611.fb 6/15/11 eligSAEs-s 7/15/11 death(FU1) 1856626

7/15/11 Torsade de Pointes Rpt # sunit-10

SAE-s/s 8/15/11 gastric perf 1279979SAE-s/s 9/15/11 gastric perf(FU) 1279979SAE-s 11/15/11 PE 1045088

11/15/11 non-inft myocard Rpt# sunit-11Perm clos 12/13/11SAE-s 1/15/12 derm bullous Rpt #sunit-12(70 SAEs)

30506 act 3/15/09 clos 11/30/111.er 3/15/10 CF,EligTemp clos 7/21/102.fb 10/4/10 CF,Elig, pptsReactivation 10/4/103.fb 4/15/11 CF4.er 9/15/11 editPerm clos 11/30/11

30601 act 9/15/07 clos 8/31/09SAE-d 1/15/08 sudden deathSAE-d 2/15/08 sudden deathSAE-d 4/15/08 sudden death1.er 7/15/08 editSAE-d 1/15/09 optic neuritis2. er 2/11/09 CF (Action Letter)3.er 3/15/09 Elig4.fb 4/17/09 RxSAE-d 7/15/09 cond abn, asystoleSAE-d 8/15/09 cardiac ischemiaSAE-d 10/15/09 asystole 1519074SAE-d 4/15/10 confusion 1640686SAE-d 7/15/10 speech impair 1983486

7/15/10 confusion (FU)1640686 SAE-d 9/15/10 speech impair (FU)1983486SAE-d 3/15/11 sensory neuropathy 1628216 5.fb 4/11/11 CF, AL, CAEPRSAE-d 6/15/11 pul art ↑BP Rpt #dasat-3SAE-d 7/15/11 ↑ CPK(FU1) 1429420SAE-d 12/15/11 ↓K 1460977(16 SAEs)

30602 act 4/15/07 clos 12/23/081. fb 9/15/07 Rx, CF, EligSAE-d 1/15/08 sudden deathSAE-d 2/15/08 sudden deathSAE-d 4/15/08 sudden death2.nr 6/15/08 editClosure 12/23/08SAE-d 1/15/09 optic neuritis 3. er 2/11/09 CF (Action Letter)SAE-d 7/15/09 cond abn, asystoleSAE-d 8/15/09 cardiac ischemiaSAE-d 10/15/09 asystole 1519074 SAE-d 4/15/10 confusion 1640686SAE-d 7/15/10 speech impair 1983486

7/15/10 confusion (FU)1640686

SAE-d 9/15/10 speech impair (FU)1983486 (90 SAEs)

30605 act 3/15/08 clos 10/13/11SAE-A 6/15/08 exacerbation of asthmaSAEs-b/e 9/15/08 blurred vision

9/15/08 MDS1.er 10/24/08 Elig, CFSAE-b/e 11/15/08 pneumomediastinum2.er 12/15/08 CFSAE-b/e 12/15/08 pneumomediastiumSuspension 3/9/09SAE-A 3/15/09 L vent insufficiencySAE-e/t 4/15/09 CSF leak, wound

complication, deathSAE-e 4/15/09 renal failSAE-e 5/15/09 pericardial eff3. er 5/27/09 CF-pt notification(AL)Reactivation 6/15/094.fb 6/15/09 CF, RxSAE-e/t 7/15/09 cerebrospinal fluid leak,

wound infectSAEs-e 7/15/09 diarrhea, renal fail (FU)

7/15/09 pericardial effSAE-e 9/15/09 edema 1670060SAE-e 2/15/10 ↑glycemia 1727021SAE-e/I 2/15/10 ↓ BP 1559936SAE-e/c 3/15/10 asteatotic eczema(FU)

1670060SAE-e/i 4/15/10 card ischemia 1203166SAE-e 5/15/10 ↑gly 1727021 FU5.er 6/15/10 CF, CAEPR updateSAEs-e/i 7/15/10 cardiac ischemia 1203166

7/15/10 hypoxia 13980667/15/10 ↓ BP 1559936

SAE-e 9/15/10 resp fail 15312416.er 12/1/10 editSAEs-e/i 1/15/11 pneumonitis (FU)1398066

1/15/11 pneumonia 1743915SAE-e 1/15/11 ARDS(FU) 1531241 7.er 1/15/11 editSAE-e/G 3/15/11 ↓plts 1392174 SAE-b 4/15/11 ARDS(FU) 1762261 SAE-e 4/15/11 ↓plts(FU) 1392174SAE-s/e 5/15/11 death 1688406SAE-e/A 5/15/11 gastric hem 1242384SAE-e/i 5/15/11 pneumonia(FU)1743915 SAE-e/A 6/15/11 gastric hem(FU)1242384 SAE-s/e 7/15/11 GI perf 1688406SAE-e/A 7/15/11 hypoxia 12768658.er 8/15/11 editSAE-e/A 8/15/11 pneumonitis(FU) 1276865SAE-e/M 8/15/11 UTI 1964323Perm clos 10/13/11SAE-e/A 11/15/11 ↑CPK 1745420(38 SAEs)

30607 act 6/15/08SAE-s 6/15/08 poss freq of fistulasSAE-s 7/15/08 rectal fistulaSAE-s/s 8/15/08 stomach hemorrhageSAE-s 8/15/08 GI fistula, hypokalemiaSAEs-s 10/15/08 sys cap leak synod

10/15/08 hrt fail-FUSAE-s/s 2/15/09 thrombosis, chest pain1.er 2/25/09 CF(Action Letter)

12

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-s/s 3/15/09 thrombosis PE (FU)SAE-s 4/15/09 pul hemorrhageSAE-s/s 4/15/09 proteinuria, ↓ hgbSAE-s 5/15/09 necrotizing pancreatitis

(Cont)30607 (Cont)

2.fb 6/15/09 Sc ∆, CF, EligSAE-s 7/15/09 muscle weakness, ↓pltsSAE-b/s 8/15/09 thrombotic microangiopathySAEs-s 8/15/09 pul hemorrhage(FU)

8/15/09 PE3.er 9/21/09 CFSAEs-b/s 12/1/09 microangiopathy 1613977

12/1/09 microangiopathy 1312527SAE-b/s 12/1/09 microangiopathy 1474081

12/1/09 microangiopathy 1395393SAEs-s 12/1/09 weakness(FU) 1491694

12/1/09 GI hem 1920386SAE-s/s 12/1/09 proteinuria(FU)1704399SAE-b/s 12/15/09 dis prog 1939558SAE-b/s 1/15/10 ↓ BP 1329500 SAE-s 1/15/10 PE (FU) 1168449SAE-s/s 2/15/10 PE 1222406SAE-s 2/15/10 septic shock, pancolitis

2009299939/sunit-7 4.er 4/15/10 CF, CAEPR updateSAE-b/s 4/15/10 disease prog (FU) 1939558 SAE-s 4/15/10 laryngeal edema 1274440


SAE-b/s 5/15/10 MI 1329500SAE-s/s 5/15/10 PE 1222406 FUSAE-s 6/15/10 dilated intest loops (FU)1733378 SAE-s 7/15/10 cereb ischemia 1788898

7/15/10 hypoxia 18422655.er 9/15/10 CFSAE-s 9/15/10 laryngeal edema(FU)1274440 6.er 10/7/10 CF, CAEPR updateSAE-s 10/15/10 CNS hem (FU) 1842265SAE-s 11/1/10 lung hem 1272083 SAE-s/c 12/1/10 pneumonitis 1226140 7.fb 1/15/11 RxSAE-s/c 1/15/11 pneumonitis (FU) 1226140 SAEs-s 1/15/11 thrombosis 1541780

1/15/11 pul ↑BP sunit-88.er 2/3/11 editSAE-s 2/15/11 MDS 1423773SAE-s 3/15/11 pheochromocytoma

Rpt #sunit-9SAE-s 4/15/11 death 1856626SAEs-s 7/15/11 death(FU1) 1856626

7/15/11 Torsade de Pointes Rpt # sunit-10

SAE-s/s 8/15/11 gastric perf 1279979SAE-s/s 9/15/11 gastric perf(FU) 1279979SAE-s 11/15/11 PE 1045088

11/15/11 non-inft myocard Rpt# sunit-119.er 12/15/11 editSAE-s 1/15/12 derm bullous Rpt #sunit-12(49 SAEs)

30610 act 3/15/081.er 12/15/08 Elig, CF2.er 12/1/09 CF. Rx3.er 12/1/09 CF4.er 2/15/10 CF5.er 9/15/10 edit6.er 1/15/11 edit

30704 act 4/15/08 clos 9/15/11SAE-s 5/15/08 liver failSAE-s 6/15/08 poss freq of fistulasSAE-s 7/15/08 rectal fistulaSAE-s/s 8/15/08 stomach hemSAE-s 8/15/08 GI fistula, hypokalemiaSAEs-s 10/15/08 sys cap leak synd

10/15/08 hrt fail-FUSAE-s/s 2/15/09 thrombosis, chest pain1.er 2/25/09 CF (Action Letter)SAE-s/s 3/15/09 thrombosis PE (FU)SAE-s 4/15/09 pul hemorrhageSAE-s/s 4/15/09 proteinuria, ↓ hgbSAE-s 5/15/09 necrotizing pancreatitis2. er 6/15/09 otherSAE-s 7/15/09 muscle weakness, ↓pltsSAE-b/s 8/15/09 thrombotic microangiopathySAEs-s 8/15/09 pul hem(FU)

8/15/09 PE3.er(RRA) 9/21/09 CF- pt notification(AL)HALT REGISTRATIONSAEs-b/s 12/1/09 microangiopathy 1613977

12/1/09 microangiopathy 1312527SAEs-b/s 12/1/09 microangiopathy 1474081

12/1/09 microangiopathy 1395393SAEs-s 12/1/09 weakness (FU) 1491694

12/1/09 GI hem 1920386SAE-s/s 12/1/09 proteinuria (FU) 1704399SAE-b/s 1/15/10 ↓ BP 1329500SAE-s 1/15/10 PE (FU) 1168499SAE-s/s 2/15/10 PE 1222406SAE-s 2/15/10 septic shock, pancolitis

2009299939/sunit-74.er 3/15/10 CF, Elig, CAEPR UpdateSAE-b/s 4/15/10 disease prog (FU) 1939558 SAE-s 4/15/10 laryngeal edema 1274440


SAE-b/s 5/15/10 MI 1329500SAE-s/s 5/15/10 PE 1222406 FUSAE-s 6/15/10 dilated intest loops (FU)1733378 SAE-s 7/15/10 cereb ischemia 1788898

7/15/10 hypoxia 1842265SAE-s 9/15/10 laryngeal edema(FU)1274445.er(RRA) 10/6/10 CF, CAEPR updateSAE-s 10/15/10 CNS hem (FU) 1842265SAE-s 11/1/10 lung hem 1272083 6.er 12/1/10 editSAE-s/c 12/1/10 pneumonitis 1226140 SAE-s/c 1/15/11 pneumonitis (FU) 1226140 SAEs-s 1/15/11 thrombosis 1541780

1/15/11 pul ↑BP sunit-8 7.er 2/15/11 edit

SAE-s 2/15/11 MDS 1423773 SAE-s 3/15/11 pheochromocytoma

Rpt #sunit-9 SAE-s 4/15/11 death 1856626

SAEs-s 7/15/11 death(FU1) 18566267/15/11 Torsade de Pointes

Rpt # sunit-108.er 8/15/11 editSAE-s/s 8/15/11 gastric perf 1279979SAE-s/s 9/15/11 gastric perf(FU) 1279979

13

Condensed List of CALGB Audit Updates Revised 2/15/129.er 10/15/11 editSAE-s 11/15/11 PE 1045088

11/15/11 non-inft myocard Rpt# sunit-11SAE-s 1/15/12 derm bullous Rpt #sunit-12(68 SAEs)

30801 act 2/15/101.fb 9/15/10 Elig2.er 12/1/10 edit3.fb 4/15/11 CF, Rx4.fb 8/15/11 Elig5.fb 12/15/11 CF, Elig

30901 act 4/15/101.fb 9/15/11 Elig,CF2.fb 2/15/12 Elig,CF

31102 act 2/15/12

40101 act 5/15/02 clos 7/30/101. 2/15/03 Rx, CF2. 9/15/03 Sc ∆, Elig, CF3. 11/15/03 Sc ∆, CF4. 11/15/04 Rx, Elig, Sc ∆, CF Memo 6/15/05(5/19/05) +Herceptin5. fb 10/15/05 Rx, Elig, Sc ∆, CF6. er 5/15/06 CF7. 5/15/07 edit, other8.fb 2/15/08 Rx, Sc ∆, CF9.fb 8/15/08 Sc ∆, otherSAE-t 6/15/09 sm bowel perf 1353951SAE-t 11/2/09 sbp (FU) 1355391SAE-t/p 2/15/10 fulminant hepatitis 29428910.nr 5/15/10 editPerm clos 7/30/10SAE-t 3/15/11 fatal embryo-fetal toxicity

Rpt # tras-1

40302 act 9/15/06 clos 7/14/101. er 5/15/07 CFSAE-l 6/15/07 pneumonitis A0640845BSAE-1 10/15/07 art thrombosis A0673950A2. fb 2/15/08 Elig3. er 4/7/08 CF, elig, action letterHALT REGISTRATIONSAEs-l 10/15/08 card infarct A0740963A

10/15/08 card fail B0532334ASAE-l/p 1/15/09 circul collapse B0551062ASAE-l/p 2/15/09 sudden death Z0000646ASAE-l/p 3/15/09 resp& hrt fail Z0000661ASAE-l/p 5/15/09 CNS tumor hem B0567619A4.er 9/22/09 CF-pt notification(AL)HALT REGISTRATION5.er 4/15/10 CF, CAEPR updatePerm clos 7/14/106.er 9/15/11 CTCAE vers 4.0 (8 SAEs)

40401 act 9/15/04 clos 6/1/111. 12/15/04 CF2. 5/15/05 edit3. 6/15/05 edit4. er 1/15/06 Elig5. er 4/15/06 Elig6. 10/15/06 edit7. 11/15/06 edit8. 5/15/07 edit9. 5/15/07 edit10. 10/15/07 edit

11.er 12/1/10 edit12.er 1/15/10 edit13.er 5/15/11 editTemp clos 5/15/11

40502 act 10/13/08 clos 11/30/11SAEs-b 11/15/08 ARDS

11/15/08 sudden death11/15/08 sudden death11/15/08 fat necrosis11/15/08 cerebellar synd


12/15/08 ↓Mg SAEs-b 12/15/08 death

12/15/08 ARDS(FU)12/15/08 PE12/15/08 rash, lower ext pain

SAE-b 12/15/08 MDS12/15/08 death from unk cause


1/15/09 sudden death(FU)1/15/09 fat necrosis(FU)1/15/09 myalgia, rash, lethargy(FU)

SAEs-b 1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm art/R atrial thrombi (FU)2/15/09 vertigo2/15/09 BBB

SAE-b/t 2/15/09 ↓Mg (FU)SAE-i 3/15/09 gastritisSAE-A 3/15/09 L vent insufficiencySAEs-b/t 3/15/09 dehydration

3/15/09 PRES3/15/09 death (FU)

SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓BP (FU)SAE-b 4/15/09 pneumonitis/pul infilt,

pericard eff (FU)4/15/09 card troponin I, card isch/infarct

SAE-b/t 4/15/09 death (FU2)4/15/09 ONJ

SAE-b/t 5/15/09 dehydration(FU)SAE-i 5/15/09 gastritisSAE-b/l 5/15/09 pneumonitis/pul infilt,

atrial fibSAE-b 5/15/09 sudden death



SAEs-b 6/15/09 CNS hemorrhage6/15/09 opportunistic infect

SAEs-b 6/15/09 pneumonitis6/15/09 cardiopul arrest6/15/09 esophageal fistula6/15/09 CNS hemorrhage, seizure6/15/09 PE, rectal infect

6/15/09 leukoencephal w/seiz, ↑ Crt 6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis

SAE-b/o 6/15/09 allergic reaction (FU)

14

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b/t 6/15/09 pneumonitis/pulm infilt

6/15/09 sudden deathSAE-i 7/15/09 ↑BP, RPLS, blurred vis,HASAEs-b 7/15/09 ↓plts – poss ITP (FU)

(Cont)40502 (Cont)

SAEs-b 7/15/09 ischemic colitis7/15/09 esophageal fistula (FU)

SAEs-b 7/15/09 N/V, HA, dizziness,confusion, dysphagia, subdural hematoma, acute CNS bleed

SAEs-b 7/15/09 spontaneous pneumothorax(FU)7/15/09 renal fail, req dialysis (FU)7/15/09 ↑card trop, ↑CPK,

card isch/infarct(FU)SAEs-b/t 7/15/09 RPLS (FU)


8/15/09 opport infect w/lymphop(FU)8/15/09 sudden death(FU)

SAEs-b 8/15/09 pul hem, pneumonitis (FU)SAEs-b/t 8/15/09 death(FU)

8/15/09 ONJ (FU)SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAEs-b 9/15/09 CNS hem(FU) 1687519


SAEs-b 10/15/09 esoph strict 127906710/15/09 cpul arrest(FU)133381410/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915


SAE-i 10/15/09 pulm thrombosis 1997299 SAE-b/i 11/2/09 death 1857033

SAE-b 12/1/09 colitis(FU) 1202538SAE-b/t 12/1/09 pneu(FU) 1392926SAE-b/s 12/1/09 microangiopathy 1613977



SAE-b/i 12/15/09 death(FU) 1857033SAE-b/s 12/15/09 dis prog 19395581.er 1/15/10 CF, Sc, eligSAE-b/i 1/15/10 ↑BP 1789687SAE-b/t 1/15/10 fatigue 1448075SAE-b/s 1/15/10 ↓ BP 1329500SAEs-b 2/15/10 sudden death 1070874

2/15/10 esophag strict (FU) 1279067SAEs-b 2/15/10 death 1858857

2/15/10 hemoptysis 1901777SAE-i 3/15/10 PE (FU) 1997299SAE-b 3/15/10 death 1900407SAEs-b 4/15/10 atrial fib 1003452

4/15/10 SBO 12365024/15/10 colitis 12952534/15/10 death 13666724/15/10 asystole (FU) 14491904/15/10 ileus, SBO, ↓Na 1544184


4/15/10 rectal pain, anal fistula 1671222SAE-b/t 4/15/10 dehydration (FU) 1710309 SAE-b/s 4/15/10 RPLS, ↑BP 1706912

SAE-b/sun 4/15/10 disease prog (FU) 1939558 SAE-I 4/15/10 CMML 10341372.er 5/14/10 CF, CAEPR updateSAEs-b/t 5/15/10 renal fail 1220746

(Cont)40502 (Cont)

SAEs-b/t 5/15/10 LV dysf 12495185/15/10 dehydration 16704735/15/10 rectal hem 1746507


6/15/10 sudden death( FU)1184694 6/15/10 confusion (FU)1206408 6/15/10 death (FU) 1366672

SAE-b/t 6/15/10 anal ulcer 1367114SAEs-b 7/15/10 sudden death 1190366

7/15/10 cere ischemia(FU)19017777/15/10 vertigo (FU) 1996104

SAEs-b/t 7/15/10 pneumonitis (FU)1249518 7/15/10 cogn disturb (FU)14480757/15/10 infect 1981052

SAE-b/i 8/15/10 cholecystitis 1035078SAE-b 8/15/10 sudden death(FU) 1070874

8/15/10 sudden death(FU) 11903668/15/10 colitis(FU) 1295253

SAE-b/t 8/15/10 rectal pain(FU)16712223.er 9/15/10 CF, elig, CAEPR updateSAE-b 9/15/10 cerebral edema(FU)1138043



SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502



1/15/11 colitis (FU2) 12952531/15/11 LV systolic dysfx 1383388

SAEs-b 1/15/11 sm bowel perf(FU) 14488481/15/11 sudden death (FU2) 14491901/15/11 ARDS 1513726

SAEs-b 1/15/11 sudden death (FU) 15843601/15/11 cellulitis 1852653

SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 10752014.fb 3/15/11 CF, elig, Rx, Sc∆,SAEs-b 3/15/11 atrial fib(FU2) 1003452


SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 1659292

SAEs-b 4/15/11 infection 16942924/15/11 ↓plts(FU) 1712748

15

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b 4/15/11 infect (FU) 1803480

4/15/11 necrot fasciitis (FU)1852653SAE-b 4/15/11 tinnitus (FU) 1897814 SAE-b/i 4/15/11 LV diastolic dysf 1892974

(Cont)40502 (Cont)

SAE-b/t 4/15/11 duodenal perf (FU)1075201 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade1357433SAEs-b 5/15/11 sudden death(FU) 1442953

5/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32

SAEs-b/t 5/15/11 anal fissure 1345682 5/15/11 LV systolic dysf1792675

SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940SAE-i 5/15/11 anaphylaxis 1819238SAEs-b 6/15/11 sudden death 1173562


SAE-b/t 6/15/11 LV systolic dysf(FU)1792675 SAE-b/s 6/15/11 death 1850786

SAE-i 6/15/11 anaphylaxis(FU)1819238 Registration Suspension 7/8/11SAEs-b 7/15/11 acute kidney inj1226625



SAE-b/v 7/15/11 syncope 17145405.fb 8/15/11 Sc ∆, Rx, CF Reactivation 8/15/11 SAEs-b 8/15/11 pulm hem 1150431

8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synd12582398/15/11 cardiac arrest 12687588/15/11 ascites 1471652

SAEs-b 8/15/11 resp fail(FU) 16456508/15/11 pneumonitis 16751888/15/11 death(FU) 1793638

SAE-b/s 8/15/11 death(FU) 1850786SAE-b/i 8/15/11 bronchial hem 1868649

SAEs-b 9/15/11 pulm hem(FU)11504319/15/11 cerebellar synd(FU)12582399/15/11 cardiac arrest(FU) 1268758




Perm clos 11/30/11SAE-b 12/15/11 optic neurop 13015346.er(RRA) 12/16/11 CF, CAEPR update

SAE-b 1/15/12 pneumothorax 16484561/15/12 death 18540331/15/12 LV sys dysf 1988955

SAE-b 2/15/12 hydrocephalus 1512246 (246 SAEs)40503 act 5/15/08 clos 11/30/11

SAEs-b 6/15/08 lung collapse, tumor necrosis, bronchopleural fistula

6/15/08 tumor necrosis, pul hem, pneumothorax

6/15/08 renal fail, proteinuria, ↓plts ,↓ANCSAE-b/c 6/15/08 osteonecrosis of spineSAE-b 8/15/08 hydrocephalusSAE-b 8/15/08 radiation retinopathySAEs-b 9/15/08 ↓plts





SAE-b 10/15/08 sudden deathSAE-s/b 10/15/08 sudden deathSAEs-b 11/15/08 ARDS

11/15/08 sudden death11/15/08 sudden death

SAEs-b 11/15/08 fat necrosis11/15/08 cerebellar synd


12/15/08 ↓Mg 12/15/08 death


SAE-b/s 12/15/08 intracerebral hemSAE-b/e 12/15/08 pneumomediastium(FU)SAE-b/t 1/15/09 L vent dysf(FU)SAEs-b 1/15/09 pul infilt

1/15/09 sudden death(FU)SAE-b 1/15/09 fat necrosis(FU)SAEs-b 1/15/09 myalgia, rash, lethargy(FU)

1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm arterial/R atrial

thrombi (FU)2/15/09 vertigo2/15/09 BBB


3/15/09 PRESSAE-b/t 3/15/09 death (FU)SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓BP (FU)SAEs-b 4/15/09 pneumonitis/pul infilt,

pericard eff (FU)4/15/09 card troponin I, card isch

SAE-b/t 4/15/09 death (FU2)4/15/09 ONJ

SAE-b/t 5/15/09 dehydration(FU)

16

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-b/l 5/15/09 pneumonitis/pul infilt,

atrial fibSAEs-b 5/15/09 sudden death

5/15/09 pneumothorax

(Cont)40503 (Cont)

SAEs-b 6/15/09 ↓plts6/15/09 peritoneal cavity infect,

GI perf, GI abscess6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis

SAEs-b 6/15/09 cardiopul arrest6/15/09 esophageal fistula6/15/09 CNS hemorrhage, seizure

SAEs-b 6/15/09 PE, rectal infect6/15/09 leukoencephalopathy

w/seizure, ↑ Crt 6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis



7/15/09 ischemic colitisSAEs-b 7/15/09 N/V, HA, dizziness,confus,

dysphagia, subdural hematoma, acute CNS bleed

7/15/09 esophageal fistula (FU)SAEs-b 7/15/09 spontan pneumothorax (FU)

7/15/09 renal fail, req dialysis (FU)SAE-b 7/15/09 ↑ card troponin, ↑ CPK,




8/15/09 sudden death(FU)8/15/09 pul hem, pneumonitis (FU)

SAEs-b/t 8/15/09 death(FU)SAEs-b/t 8/15/09 ONJ(FU)SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizure1.fb 8/15/09 CFSAEs-b 9/15/09 CNS hem(FU) 1687519


SAEs-b 10/15/09 esoph strict 127906710/15/09 c pul arrest(FU)133381410/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915





SAE-b/i 12/15/09 death(FU) 1857033SAE-b/s 12/15/09 dis prog 1939558SAE-b/t 1/15/10 fatigue 1448075

SAE-b/s 1/15/10 ↓ BP 1329500SAEs-b 2/15/10 sudden death 1070874

2/15/10 esoph strict, esophagitis (FU) 1279067

(Cont)40503 (Cont)

SAEs-b 2/15/10 death 18588572/15/10 hemoptysis 1901777

SAE-b 3/15/10 death 1900407 SAEs-b 4/15/10 atrial fib 1003452




SAE-b/s 4/15/10 RPLS, ↑BP 1706912SAE-b/sun 4/15/10 disease prog (FU) 1939558 SAE-I 4/15/10 CMML 10341372.er 5/15/10 CF, Rx, Sc∆, ppt letterSAEs-b/t 5/15/10 renal fail 1220746

5/15/10 LV dysf 12495185/15/10 dehydration 1670473

SAE-b/t 5/15/10 rectal hem 1746507SAE-b/s 5/15/10 MI 1329500SAEs-b 6/15/10 cerebral edema 1138043





SAE-b/i 8/15/10 cholecystitis 1035078SAE-b 8/15/10 sudden death 1070874(FU)

8/15/10 sudden death 1190366(FU)8/15/10 colitis 1295253(FU)

SAE-b/t 8/15/10 rectal pain 1671222(FU)3.er 9/15/10 CF, CAEPR updateSAE-b 9/15/10 cerebral edema(FU)1138043



SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 1659292

SAEs-b 10/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502

SAE-b/l 10/15/10 ONJ 19639404.fb 11/1/10 Sc SAE-b/i 11/1/10 cholecystitis(FU) 1035078SAE-b 11/1/10 cardiac arrest(FU)1544184

11/1/10 sudden death 1584360SAE-b 12/1/10 osteonecrosis 1470711

17

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b 1/15/11 atrial fib (FU) 1003452

1/15/11 colitis (FU2) 12952531/15/11 LV systolic dysfx 13833881/15/11 sm bowel perf(FU) 1448848

(Cont)40503 (Cont)

SAEs-b 1/15/11 sudden death (FU2) 14491901/15/11 ARDS 15137261/15/11 sudden death (FU) 15843601/15/11 cellulitis 1852653

SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 1075201

SAEs-b 3/15/11 atrial fib(FU2) 10034523/15/11 pneumonitis/pulm infilt14837493/15/11 tinnitus 1897814

SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts(FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU)1075201 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade13574335/15/11 sudden death(FU) 1442953

SAEs-b 5/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32


SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 19639405. fb 6/15/11 CF, Rx, Sc∆,elig

SAEs-b 6/15/11 sudden death 11735626/15/11 pneumonitis(FU)14837496/15/11 necrotizing fasciitis 16532476/15/11 sudden death(FU) 1706673

SAE-b 6/15/11 ARDS 1727423SAE-b/t 6/15/11 LV systolic dysf(FU)1792675 SAE-b/s 6/15/11 death 1850786

SAEs-b 7/15/11 acute kidney inj 12266257/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 13352677/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)16532477/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 17611917/15/11 death 1793638


SAE-b/v 7/15/11 syncope 1714540 SAEs-b 8/15/11 pulm hem 1150431

8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synd 12582398/15/11 cardiac arrest 1268758

8/15/11 ascites 14716528/15/11 resp fail(FU) 1645650

SAEs-b 8/15/11 pneumonitis 16751888/15/11 death(FU) 1793638


(Cont)40503 (Cont)

SAEs-b 9/15/11 pulm hem(FU) 11504319/15/11 cerebellar synd(FU)12582399/15/11 cardiac arrest(FU) 1268758




Perm clos 11/30/11SAE-b 12/15/11 optic neurop 13015346.er(RRA) 12/16/11 CF, CAEPR updateSAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955

SAE-b 2/15/12 hydrocephalus 1512246 (254 SAEs)

40504 act 6/30/06 clos 11/6/061. 9/15/06 edit2.er 4/15/08 editSAEs-b 5/15/08 necrotizing fasciitis


SAEs-b 6/15/08 lung collapse, tumor necrosis, bronchopleural fistula

6/15/08 tumor necrosis, pul SAE-b 6/15/08 renal fail, proteinuria,

↓plts , ↓ANC SAE-b/c 6/15/08 osteonecrosis of spineSAEs-b 8/15/08 hydrocephalus

8/15/08 radiation retinopathySAEs-b/e 9/15/08 MDS

9/15/08 blurred visionSAEs-b 9/15/08 non-infectious ext otitis

w/tympanic perf 9/15/08 ↓plts

SAE-s/b 10/15/08 sudden deathSAE-b/v 10/15/08 sudden deathSAEs-b 10/15/08 sudden death

10/15/08 ext otitis (non-infect) w/tympanic perf-FU

SAE-b 10/15/08 sudden deathSAE-b/r 11/15/08 hemoptysisSAE-b/e 11/15/08 pneumomediastinum SAEs-b 11/15/08 cerebellar synd

11/15/08 fat necrosis SAEs-b 11/15/08 sudden death (FU)

11/15/08 sudden death11/15/08 ARDS

SAE-b/o 12/15/08 L vent systolic dysfSAEs-b/t 12/15/08 L vent dysf

12/15/08 ↓Mg 12/15/08 death

SAE-b 12/15/08 ARDS(FU)SAEs-b 12/15/08 PE

18

Condensed List of CALGB Audit Updates Revised 2/15/1212/15/08 rash, lower ext pain12/15/08 MDS

SAE-b 12/15/08 death from unk causeSAE-b/s 12/15/08 intracerebral hemorrhageSAE-b/e 12/15/08 pneumomediastium(FU)SAE-b/t 1/15/09 L vent dysf(FU)SAEs-b 1/15/09 pul infilt

1/15/09 sudden death(FU)(Cont)

40504 (Cont)SAEs-b 1/15/09 fat necrosis(FU)

1/15/09 myalgia, rash, lethargy(FU)1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm arter/R atrial thrombi (FU)2/15/09 vertigo2/15/09 BBB

SAE-b/t 2/15/09 ↓Mg (FU)SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓BP(FU)SAEs-b/t 3/15/09 dehydration

3/15/09 PRES3/15/09 death (FU)

SAE-b 4/15/09 pneumonitis/pul infilt, pericard eff (FU)

SAE-b 4/15/09 card troponin I, card isch/infarctSAE-b/t 4/15/09 death (FU2)




SAEs-b 6/15/09 CNS hem6/15/09 opportunistic infect6/15/09 pneumonitis6/15/09 cardiopul arrest6/15/09 esophageal fistula

SAEs-b 6/15/09 CNS hem, seizure6/15/09 PE, rectal infect

6/15/09 leukoencephalopathy w/seizure, ↑ Crt

SAEs-b 6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis


6/15/09 sudden deathSAEs-b 7/15/09 ↓plts – poss ITP (FU)SAEs-b 7/15/09 ischemic colitis

7/15/09 esophageal fistula (FU)SAEs-b 7/15/09 N/V, HA, dizziness,confus,


7/15/09 spontan pneumothorax (FU)7/15/09 renal fail, req dialysis (FU)

SAE-b 7/15/09 ↑ card troponin, ↑ CPK, card ischemia/infarct(FU)

SAEs-b/t 7/15/09 RPLS (FU)7/15/09 death

SAEs-b 8/15/09 CNS hemorrhage(FU)8/15/09 opportunistic infect

assoc w/lymphopenia(FU)SAEs-b 8/15/09 sudden death(FU)

8/15/09 pul hem, pneumonitis(FU)SAEs-b/t 8/15/09 death(FU)

8/15/09 ONJ(FU)SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAEs-b 9/15/09 CNS hem(FU) 1687519


SAEs-b 10/15/09 esoph strict 127906710/15/09 c pul arrest(FU)1333814

(Cont)40504 (Cont)

SAEs-b 10/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915





SAE-b/i 12/15/09 death(FU) 1857033SAE-b/s 12/15/09 dis prog 1939558SAE-b/t 1/15/10 fatigue 1448075SAE-b/s 1/15/10 ↓ BP 1329500SAEs-b 2/15/10 sudden death 1070874

2/15/10 esoph strict(FU) 12790672/15/10 death 1858857

SAE-b 2/15/10 hemoptysis 1901777SAE-b 3/15/10 death 1900407SAEs-b 4/15/10 atrial fib 1003452

4/15/10 SBO 12365024/15/10 colitis 1295253

SAEs-b 4/15/10 death 13666724/15/10 asystole (FU) 14491904/15/10 ileus, SBO, ↓Na 1544184



SAE-b/s 4/15/10 RPLS, ↑BP 1706912SAE-b/sun 4/15/10 disease prog (FU) 1939558 SAEs-b/t 5/15/10 renal fail 1220746

5/15/10 LV dysf 12495185/15/10 dehydration 16704735/15/10 rectal hem 1746507



SAE-b 6/15/10 death (FU) 1366672 SAE-b/t 6/15/10 anal ulcer 1367114

SAEs-b 7/15/10 sudden death 11903667/15/10 cere ischemia(FU)19017777/15/10 vertigo (FU) 1996104




SAE-b/t 8/15/10 rectal pain 1671222(FU)SAE-b 9/15/10 cerebral edema(FU)1138043

9/15/10 death(FU) 1900497

19

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-b/s 9/15/10 RPLS(FU) 1706912 SAEs-b/t 10/15/10 renal fail(FU) 1220746


SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 1448848

(Cont)40504 (Cont)

SAEs-b 10/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502

SAE-b/l 10/15/10 ONJ 1963940 SAE-b/i 11/1/10 cholecystitis(FU) 1035078

SAE-b 11/1/10 cardiac arrest(FU)154418411/1/10 sudden death 1584360

SAE-b 12/1/10 osteonecrosis 1470711(147 SAEs)SAEs in grey are posted but not broadcast

40601 act 12/1/08SAE-l/p 1/15/09 circulat collapse B0551062ASAE-l/p 2/15/09 sudden death Z0000646ASAE-l/p 3/15/09 resp & heart fail Z0000661ASAE-l/p 5/15/09 CNS tumor hem B0567619ASAE-t 6/15/09 sml bowel perf 13539511.er 9/22/09 CF-pt notification(AL)HALT REGISTRATIONSAE-t 11/2/09 sm bowel perf (FU)1353951SAE-t/p 2/15/10 fulminant hepatitis 2942892.fb 4/15/10 CF, Rx, Sc∆3.er 6/15/10 CF, CAEPR update4.er 9/15/10 editSAE-t 3/15/11 fatal embryo-fetal toxicity

Rpt # tras-15.fb 7/15/11 CF, Rx, Sc∆6.er 2/15/12 CF, CAEPR update7.er 2/15/12 edit(8 SAEs)

40603 act 5/15/09SAEs-b 6/15/09 ↓plts


6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis



w/seizure, ↑ Crt 6/15/09 hydronephrosis, kidney hem

SAE-b 6/15/09 hemolysisSAE-b/o 6/15/09 allergic reaction (FU)SAEs-b/t 6/15/09 pneumonitis/pulm infilt



SAEs-b 7/15/09 N/V, HA, dizziness,confus, dysphagia, subdural hematoma, acute CNS bleed

7/15/09 spontan pneumothorax (FU)

SAEs-b 7/15/09 renal fail, req dialysis (FU)7/15/09 ↑ card troponin, ↑ CPK,


7/15/09 deathSAEs-b 8/15/09 CNS hem(FU)


(Cont)40603 (Cont)



SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAEs-b 9/15/09 CNS hem(FU) 1687519












4/15/10 rectal pain, anal fistula 1671222SAE-b/t 4/15/10 dehydration (FU) 1710309 SAE-b/s 4/15/10 RPLS, ↑BP 1706912SAE-b/sun 4/15/10 disease prog (FU) 1939558 1.fb 5/15/10 CFSAEs-b/t 5/15/10 renal fail 1220746




SAE-b/t 6/15/10 anal ulcer 1367114 SAEs-b 7/15/10 sudden death 1190366

20

Condensed List of CALGB Audit Updates Revised 2/15/127/15/10 cere ischemia(FU)19017777/15/10 vertigo (FU) 1996104


2.er 8/15/10 Bev CAEPR update, CF

SAE-b/i 8/15/10 cholecystitis 1035078

(Cont)40603 (Cont)

SAE-b 8/15/10 sudden death 1070874(FU)8/15/10 sudden death 1190366(FU)8/15/10 colitis 1295253(FU)


9/15/10 death(FU) 1900497SAE-b/s 9/15/10 RPLS(FU) 1706912

SAEs-b/t 10/15/10 renal fail(FU) 122074610/15/10 anal ulcer(FU) 136711410/15/10 dehydration (FU) 156186910/15/10 dehydration(FU) 167047310/15/10 rectal bleeding (FU)1746507


SAEs-b 10/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502

SAE-b/l 10/15/10 ONJ 1963940 SAE-b/i 11/1/10 cholecystitis(FU) 1035078

SAE-b 11/1/10 cardiac arrest(FU) 154418411/1/10 sudden death 1584360

SAE-b 12/1/10 osteonecrosis 1470711 3.er 12/1/10 CF, Sc

SAEs-b 1/15/11 atrial fib (FU) 10034521/15/11 colitis (FU2) 12952531/15/11 LV systolic dysfx 13833881/15/11 smbowel perf(FU) 14488481/15/11 sudden death (FU2)14491901/15/11 ARDS 15137261/15/11 sudden death (FU) 15843601/15/11 cellulitis 1852653

4.er 2/15/11 CF SAE-b 2/15/11 encephalopathy (FU) 1226745

SAE-b/t 2/15/11 duod-aortic fistula 1075201 SAEs-b 3/15/11 atrial fib(FU2) 1003452


SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thromb 15747054/15/11 ARDS(FU) 1659292

SAEs-b 4/15/11 infect 16942924/15/11 ↓plts(FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis(FU) 18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU) 1075201 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamp 13574335/15/11 sudden death(FU) 14429535/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 1694292

5/15/11 sudden death 1706673SAEs-b 5/15/11 wound comp 1751032

5/15/11 death 1761191SAEs-b 5/15/11 herpes encephalitis Rpt -bev-32SAEs-b/t 5/15/11 anal fissure 1345682

5/15/11 LV systolic dysf 1792675SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940

(Cont)

40603 (Cont)SAEs-b 6/15/11 sudden death 1173562

6/15/11 pneumonitis(FU) 14837496/15/11 necrotizing fasciitis 1653247

SAEs-b 6/15/11 sudden death(FU) 17066736/15/11 ARDS 1727423





8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synd 12582398/15/11 cardiac arrest 12687588/15/11 ascites 14716528/15/11 resp fail(FU) 16456508/15/11 pneumonitis 16751888/15/11 death(FU) 1793638




SAE-b/i 10/15/11 ↑BP 1059673Temp Susp 11/10/11SAEs-b/i 11/15/11 ↑BP(FU) 1059673 SAE-b 11/15/11 AML(FU) 1178143


SAE-b 12/15/11 optic neurop 13015345.er(RRA) 12/16/11 CF, CAEPR updateSAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955

Reactivation 2/15/126.er 2/15/12 CF, pptSAE-b 2/15/12 hydrocephalus 1512246

(196 SAEs)

40903 act 2/15/12

49801 act 12/15/99 clos 7/14/061. 9/15/00 Rx,CF2. 12/15/01 Rx, Elig, CF3. 2/15/02 CF

21

Condensed List of CALGB Audit Updates Revised 2/15/124. 5/15/04 edit5. 11/15/04 edit6. 7/15/05 edit7.nr 5/15/07 edit8.er 8/15/10 edit

49805 act 1/15/99 clos 5/31/021. in orig prot2. 12/15/00 edit3. 6/15/01 CF, Sc editSAE 7/15/02 diarrhea, loss of appetite,

vaginal blding/spotting5. 6/15/03 Sc fb Sc Rx7. fb 6/15/04 Sc Rx, CF8. fb 7/15/05 Rx, CF9. fb 2/15/07 Rx, CF10.er 8/15/11 bld draw

49907 act 9/1/01 clos 12/29/061. 10/15/01 Elig, CF2. 11/15/01 editSuspension 11/12/01Reactivation 4/15/023. 4/15/02 CF, Rx4. 5/15/02 edit5. 6/15/02 edit6. 7/15/02 edit7. 8/15/02 edit8. 11/15/02 Elig, Rx, CF9. 1/15/03 edit10. 2/15/03 editSAE 5/15/03(5/2/03) infection w/↓ ctsSusp – Arm 1 (Capecitabine) 7/14/03SAE 7/15/03(7/14/03) death – diarrheaSAE 8/15/03(8/15/03) ↓BP/inf/febrile ↓cts11. 10/1/03 Rx, CF, EligReOpen Arm 1 (Capecitabine) 10/1/0312. 10/15/04 Rx, Sc∆, Elig, CF13. 4/15/05 EligSAEs 5/15/05(5/15/05) gluteal myositis

5/15/05(5/15/05) hep lesions, ↑ LFTsMemo 6/15/05(5/19/05) +HerceptinSAEs 10/15/05(10/15/05) hemorrhagic necrotic colitis

10/15/05(10/15/05) sudden death14. 5/15/06 Sc, Rx, Elig, CF15. 4/15/07 ScCF(7 SAEs)

49909 act 6/15/00 clos 4/30/051.er 7/15/00 Rx, CF2. fb 2/15/01 Rx, CF3. er 6/15/01 Elig, CF4. fb 9/15/01 Rx, Elig, CF5. fb 1/15/02 Sc Rx, Elig, CF6. fb 7/26/02 Sc Rx, Elig, CF

Arm C susp7. fb 7/26/02 Sc Rx, Elig, CF

Arm C re-open8. fb 4/15/03 Sc Elig, CF9. fb 1/15/04 Sc Rx, CF10. fb 8/15/04 Rx, CF

11. fb 12/15/04 Sc CF12. er 4/15/05 edit13.fb 6/15/05 Sc Rx14.fb 12/15/05 Sc CF15.fb 8/15/06 Sc CF16. fb 10/15/08 Sc CF17.er 6/15/09 edit18.er 8/15/10 CF

50102 act 12/15/01 clos 9/15/081. 3/15/02 edit2. 4/15/03 Sc , Rx, CF3. 1/15/04 edit4. 5/15/04 edit5. 10/15/04 editAct Ltr 11/2/04 hepatitis, hep fail6. fb 12/15/04 Elig, CF7. er 10/15/05 Elig, CF8. er 3/15/06 CF9. fb 1/15/07 Sc , Elig, CF10. er 3/15/07 CFAct Ltr 3/15/07 PML11. fb 5/15/07 CF12. er 7/15/07 CF13. er 9/15/07 CF14. er 4/15/10 edit15. er 10/15/10 Rx

50201 act 4/15/04 clos 4/13/071. 10/15/04 editAct Ltr 11/2/04 hepatitis, hep failSAE 11/15/04(11/15/04) AML2. 12/15/04 CF3. 12/15/05 Sc , CF 4.fb 9/15/06 CF5. nr 11/15/06 edit6.fb 4/15/07 edit,closure(1 SAE)

50202 act 10/15/04 clos 11/6/09Act Ltr 11/2/04 hepatitis, hep fail1. 12/15/04 CF2. 12/15/05 Elig , CF, ppt3. er 9/15/06 CF4. nr 1/15/07 edit5. fb 6/15/07 CFSAE-G 9/15/07 sudden death6. er 10/15/07 CF7. nr 2/15/08 editSAE-b/r 11/15/08 hemoptysisClosure 11/6/098.er 6/17/10 CF, CAEPR update9.er 2/15/11 Rx, CTCAE vers 4.0(2 SAEs)

50203 act 5/15/04 clos 9/29/061. 10/15/04 edit2. 11/15/04 CF3. 2/15/06 Rx, Sc ∆4. 7/15/06 edit5. 12/15/07 edit6.er 8/15/11 CTCAE vers 4.0

50205 act 4/20/05 clos 5/26/061. 3/15/06 CF2. 1/15/07 edit

22

Condensed List of CALGB Audit Updates Revised 2/15/12

50303 act 5/2/051. 1/15/06 Rx, ppt, CF2. fb 6/30/06 Rx, Elig, CF3. fb 3/15/07 Sc Δ, CF4. 3/15/07 edit5. fb 7/15/07 CF6.fb 8/15/08 CF, otherSAE-b/r 11/15/08 hemoptysis7.er 4/15/09 Sc Δ8.er 4/15/10 edit9.er 6/17/10 CF, CAEPR update10.er 11/1/10 edit11.er 1/15/11 edit12.fb 4/15/11 Sc Δ, CF

(1 SAE)

50401 act 3/15/06 clos 4/25/11SAEs 3/15/06(3/15/06) card ischemia/infarct

card troponin, dizziness,pain: card/heart, autoimmune, antiphospholipid synd

3/15/06(3/15/06) ↓ pltsAL 4/15/06(3/29/06) fetal development1. er 4/15/06 CFSAEs 4/15/06(4/15/06) erythema multiforme

4/15/06(4/15/06) hypoxia,R-sided CHFSAE 5/15/06(5/15/06) infect encephalitis, seizureSAE 7/15/06(7/15/06) dyspnea, pl eff, LE EdemaSAEs 8/15/06(8/15/06) ↑ Crt

8/15/06(8/15/06) pul infilt, hypoxiaSAE 9/15/06(9/15/06) motor neurop, somnolence,

speech impair2. fb 12/15/06 Elig3. fb 3/15/07 CF4. fb 6/15/07 CFSAE-l 6/15/07 leukoencephalopathySAEs-l 7/15/07 tumor lysis synd

7/15/07 peripheral arterial ischemia w/ soft tiss necrosis/lower ext

SAE-l 8/15/07 tumor flare5. fb 9/15/07 Sc, Elig, CFSAE-l 9/15/07 central retinal vein occlusionSAE-1 10/15/07 infect w/↓ ANC, pneumonia,

deathSAEs-1 11/15/07 ↑ serum HCG, pos urine HCG

11/15/07 resp fail6.er 12/15/07 Sc SAE-1 12/15/07 tumor lysis synod & reactSAE-l 2/15/08 tumor lysis synod & reactSAE-l 5/15/08 clonal evolution & prog from


7/15/08 meningoencephalitis7.er 8/15/08 Elig, CFSAE-l 8/15/08 psoriasisSAE-l 9/15/08 GIST SAE-b/l 9/15/08 sudden deathSAE-l 10/15/08 2nd malig, GIST (FU)SAE-b/r 11/15/08 hemoptysis

SAE-l 11/15/08 sudden deathSAE-l 12/15/08 sudden death (FU)SAE-b/l 2/15/09 sudden death (FU)SAE-b/l 3/15/09 SOB, deathSAE-b/l 4/15/09 death

(Cont)50401(Cont)

SAE-l 4/15/09 prog multifocal leukoencephalopathy

SAE-b/l 5/15/09 pneumonitis/pul infilt, atrial fib

SAE-b/l 7/15/09 death (FU)SAE-l 8/15/09 lymphoblastic leukSAEs-l 9/15/09 ↑ Crt phos 1498428

9/15/09 laryn edema 1871314SAE-l 11/2/09 laryn edema(FU) 1871314SAE-l 12/15/09 pneumonitis/pul infilt13967948.er 1/15/10 Elig, CFSAE-l 1/15/10 ↑ Crt phos(FU)1498428SAE-l 3/15/10 pneumonitis/pul infilt

1396794 (FU)9.er 3/16/10 CF, CAEPR updateHALT REGISTRATIONSAE-b/l 4/15/10 pneumonitis, atrial fib 1277486SAE-l 5/15/10 lymph leuk 1203233(FU)10.er 6/17/10 CF, CAEPR update

SAE-l/b 8/15/10 ONJ 1164386SAE-b/l 10/15/10 ONJ 1963940SAEs-l 10/15/10 meningitis 1528263

10/15/10 hemolysis 1740343 11.er 12/15/10 CFSAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-l 1/15/11 hemolysis (FU)174034312.fb 2/15/11 CF, CTCAE vers 4.0

SAE-l 3/15/11 hemolysis 11306453/15/11 cogn disturb 11684333/15/11 colitis 1518659

SAEs-l 4/15/11 ↑ creatinine 13561034/15/11 ↑ creatinine 13846824/15/11 meningitis(FU)15282634/15/11 viscer art ischemia 18018244/15/11 ↑ creatinine 1993413

Temp clos 4/25/1113.er 5/15/11 CF, Action LetterSAE-b/l 5/15/11 ONJ 1963940SAEs-l 5/15/11 hemolysis 1094914

5/15/11 hemolysis(FU)11306455/15/11 cogn disturb(FU)11684335/15/11 neoplasm(FU) 13846825/15/11 ischemic colitis(FU)1518659

SAE-l 7/15/11 cardiac arrest 193244014.er 8/15/11 CFSAE-l/b 8/15/11 choroidal eff 1800822SAE-l 8/15/11 AML 1921183SAE-l/b 9/15/11 multi-organ fail 150693015.fb 9/30/11 CF, CAEPR updateSAEs-l/b 10/15/11 multi-organ fail(FU)1506930


50402 act 6/15/05 clos 6/30/061. 11/15/05 ppt2. 12/15/05 Rx

23

Condensed List of CALGB Audit Updates Revised 2/15/123. 1/15/06 Rx, CF4. 3/15/07 edit5.er 8/15/11 CTCAE vers 4.0

50403 act 6/30/06 clos 6/25/101. 9/15/06 edit2. fb 12/15/06 Sc, CF3. fb 3/15/07 CF4. fb 5/15/07 Elig, CF5. fb 8/15/07 Rx, CF6. er 2/15/08 Elig, CFSAE-b 7/15/08 prolonged OTc interval,

cardiac troponinSAE-b/l 9/15/08 sudden deathSAE-b/r 11/15/08 hemoptysisSAE-b/A 11/15/08 colitisSAE-b 1/15/09 ↓ K, ARDS, renal fail7. er 1/15/09 Sc, CF8. er 2/10/09 CF (Action Letter)SAE-b/l 2/15/09 sudden death (FU)SAE-b/A 2/15/09 septic shk, acidosis, colitis (FU)SAE-b 2/15/09 renal fail, ↑bili, ↓K, ARDS (FU)SAE-b/l 3/15/09 SOB, deathSAE-b/A 3/15/09 infect, acidosis, colitis (FU2)SAE-b/l 4/15/09 deathSAE-b 4/15/09 ARDSSAE-b/l 7/15/09 death (FU)SAE-b 9/15/09 LV dysf 1887123SAE-b 12/1/09 ARDS 1073953

12/1/09 vent sys dysf 1850085SAE-b/v 12/1/09 sudden death 1495143SAEs-b 2/15/10 ARDS 1649799

2/15/10 resp fail 1705612SAE-b/A 2/15/10 AV block 16587629.er 3/15/10 CF, ScSAE-b/v 3/15/10 multi-organ fail(FU)1495143SAE-b 3/15/10 death 161731910.er 6/15/10 CF, CAEPR updateSAE-b/v 6/15/10 multi-organ fail (FU2)1495143SAE-b 6/15/10 ARDS, hypoxia1649799

6/15/10 hypoxia 182690211.er 6/17/10 CF, CAEPR updatePerm clos 6/25/10SAE-b 7/15/10 LV sys dysf (FU) 1850085

7/15/10 LV sys dysf (FU) 1887123 SAE-l/b 8/15/10 ONJ 1164386SAE-b 8/15/10 death (FU) 1617319SAE-b/A 8/15/10 conduction abn 1658762SAE-b 9/15/10 resp fail(FU) 1705612 12. er 10/15/10 CFSAE-b/f 10/15/10 colitis 1358314SAE-b 12/1/10 ARDS 176221SAE-b/l 12/1/10 sudden death 162841113.er 1/15/11 edit

SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-b 1/15/11 hypoxia(FU) 1826902

SAE-b 4/15/11 ARDS(FU) 1762261 SAE-l/b 8/15/11 choroidal eff 1800822SAE-b/f 8/15/11 esophagitis 1033338SAE-b 8/15/11 typhlitis 1959720SAE-l/b 9/15/11 multi-organ fail 1506930SAE-b/f 9/15/11 esophagitis(FU)103333814.er 10/15/11 Sc

SAEs-l/b 10/15/11 multi-organ fail(FU)150693010/15/11 choroidal effus(FU)1800822

(41 SAEs)

50404 act 3/15/06 clos 12/29/061. 6/30/06 CFSAE 8/15/06(8/15/06) torsade de pointes, v tach, at fib,

LV dysf, ↓wbc, bld infectSAE 10/15/06(10/15/06) aspirat, peritoneal cavity hem,

blad obst, somnolence, creat, abd dist, febrile ↓ cts, hypoxia,

2. 3/15/07 FDA alert(2 SAEs)

50501 act 11/15/07 clos 7/7/11SAEs-1 11/15/07 ↑ serum HCG, pos urine HCG

11/15/07 resp failSAE-1 12/15/07 tumor lysis synd, tumor flare reactSAE-1 2/15/08 tumor lysis synd, tumor flare react1. 2/15/08 editSAE-l 5/15/08 clonal evolution & prog from


7/15/08 meningoencephalitisSAE-b 7/15/08 prolong OTc interv, card troponSAE-l 8/15/08 psoriasisSAE-l 9/15/08 GISTSAE-b/l 9/15/08 sudden deathSAE-l 10/15/08 2nd malig, GIST-FUSAE-l 11/15/08 sudden deathSAE-b/A 11/15/08 colitisTemp susp 12/3/08SAE-l 12/15/08 sudden death-FUSAE-b 1/15/09 ↓K, ARDS, renal fail2. er 2/10/09 CF (Action Letter)SAE-b/l 2/15/09 sudden death (FU)SAE-b/A 2/15/09 septic shk, acidosis, colitis(FU)SAE-b 2/15/09 renal fail, ↑bili, ↓K, ARDS(FU)SAE-b/l 3/15/09 SOB, deathSAE-b/A 3/15/09 infect, acidosis, colitis (FU2)SAE-b/l 4/15/09 deathSAE-l 4/15/09 prog multif leukoencephalSAE-b 4/15/09 ARDSReactivation 4/27/09SAE-b/l 5/15/09 pneumonitis/pul infilt, SAE-b/l 7/15/09 death (FU)SAE-l 8/15/09 lymphoblastic leukSAEs-l 9/15/09 ↑ Crt phos 1498428

9/15/09 laryn edema 1871314SAE-b 9/15/09 LV dysf 18871233.er 10/15/09 Elig, CFSAE-l 11/2/09 laryn edema (FU) 1871314

SAE-b 12/1/09 ARDS 107395312/1/09 vent sys dysf 1850085

SAE-b/v 12/1/09 sudden death 1495143SAE-l 12/15/09 pneumonitis/pul infilt13967944.er 1/15/10 Elig, CFSAE-l 1/15/10 ↑ Crt phos (FU)1498428SAEs-b 2/15/10 ARDS 1649799

2/15/10 resp fail 1705612SAE-b/A 2/15/10 AV block 16587625.er 3/15/10 editSAE-l 3/15/10 pneumon/pul infilt 1396794 (FU)SAE-b/v 3/15/10 multi-organ fail 1495143(FU)SAE-b 3/15/10 death 1617319

24

Condensed List of CALGB Audit Updates Revised 2/15/126.er 3/16/10 CF, CAEPR updateHALT REGISTRATIONSAE-b/l 4/15/10 pneumonitis, 1277486SAE-l 5/15/10 lymph leuk 1203233(FU)7.er 6/15/10 CF, CAEPR updateSAE-b/v 6/15/10 multi-organ fail (FU2)1495143

(Cont)50501(Cont)

SAE-b 6/15/10 ARDS, hypoxia16497996/15/10 hypoxia 1826902

SAE-b 7/15/10 LV sys dysf (FU) 18500857/15/10 LV sys dysf (FU) 1887123

SAE-l/b 8/15/10 ONJ 1164386SAE-b 8/15/10 death 1617319 (FU)SAE-b/A 8/15/10 conduction abn 1658762SAE-b 9/15/10 resp fail(FU) 1705612 SAE-b/l 10/15/10 ONJ 1963940

SAEs-l 10/15/10 meningitis 152826310/15/10 hemolysis 1740343

SAE-b/f 10/15/10 colitis 1358314SAE-b 12/1/10 ARDS 176221SAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-l 1/15/11 hemolysis(FU)1740343 SAE-b 1/15/11 hypoxia(FU) 18269028.er 2/15/11 CTCAE vers 4.0SAE-l 3/15/11 hemolysis 1130645


SAEs-l 4/15/11 ↑ creatinine 13561034/15/11 ↑ creatinine 1384682

SAEs-l 4/15/11 meningitis(FU)15282634/15/11 viscer art ischemia 18018244/15/11 ↑ creatinine 1993413

SAE-b 4/15/11 ARDS(FU) 1762261 9.er 5/15/11 CF, Action letterSAE-b/l 5/15/11 ONJ 1963940

SAEs-l 5/15/11 hemolysis 10949145/15/11 hemolysis(FU)11306455/15/11 cogn disturb(FU)11684335/15/11 neoplasm(FU) 13846825/15/11 ischemic colitis(FU)1518659

SAE-d 5/15/11 sens neuropathy(FU)162821610.er 6/15/11 CFSAE-l 7/15/11 cardiac arrest 1932440SAE-l/b 8/15/11 choroidal eff 1800822SAE-l 8/15/11 AML 1921183

SAE-b/f 8/15/11 esophagitis 1033338SAE-b 8/15/11 typhlitis 1959720

SAE-l/b 9/15/11 multi-organ fail 1506930SAE-b/f 9/15/11 esophagitis(FU)1033338 11.fb 9/30/11 CF, CAEPR updateSAEs-l/b 10/15/11 multi-organ fail(FU)1506930


50502 act 4/15/06 clos 12/4/071. 5/15/06 edit2. fb 6/30/06 CFSAE 6/30/06(6/30/06) toxic epidermal necrolysisTemp susp 7/19/06 (drug supply)Reactivation 8/8/063. fb 4/15/07 Sc, Rx, CFSAE-S 7/15/07 pneumonitis/pul infilt4. er 8/15/07 CF

5. fb 9/15/07 Elig, CFSAE-S 10/15/07 pneumonitis/pul infilt6. er 11/15/07 edit7. fb 2/15/08 RxSAE-s 4/15/08 tumor flare, ileus, pl eff 8.er 6/15/10 CF, CAEPR update (4 SAEs)

50602 act 6/2/08 clos 9/15/091.fb 9/15/08 CF, ScTemp susp 1/26/092.er 6/15/11 CTCAE version 4.0

50604 act 5/15/101.fb 11/1/10 Sc , Elig2.fb 4/15/11 Sc , Elig3.er 7/15/11 edit4.fb 9/15/11 Rx, CF5.er 1/15/12 edit6.er 2/15/12 CF, Elig,other

50701 act 3/15/08 clos 7/24/09

1. er 5/15/08 CFTemp susp 9/15/08 (planned eval)2.er 11/15/08 CFSAE-b/r 11/15/08 hemoptysisSAE-e 3/15/09 lymphomaSAE-e 4/15/09 loss of consciousness3.er 5/15/09 CF4.er 6/15/09 otherPerm clos 7/24/095.er 6/17/10 CF, CAEPR update 6.er 8/15/10 Sc7.er 6/15/11 CTCAE version 4.0 (3 SAEs)

50801 act 5/15/101.fb 11/1/10 Sc , CF2.fb 4/15/11 Sc , Elig3.fb 7/15/11 CF4.fb 9/15/11 Rx, CF5.er 1/15/12 edit6.er 2/15/12 CF, Elig,other

50803 act 6/15/10 clos 9/30/11SAE-l/b 8/15/10 ONJ 1164386SAE-b/l 10/15/10 ONJ 1963940SAEs-l 10/15/10 meningitis 1528263

10/15/10 hemolysis 1740343 1.fb 11/15/10 Rx, CF SAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-l 1/15/11 hemolysis(FU)1740343SAE-l 3/15/11 hemolysis11306453/15/11 cogn disturb 11684333/15/11 colitis 15186592.er 4/1/11 editSAEs-l 4/15/11 ↑ creatinine 1356103

4/15/11 ↑ creatinine 13846824/15/11 meningitis(FU)15282634/15/11 viscer art ischemia 18018244/15/11 ↑ creatinine 1993413

3.er 5/15/11 CF, Action letterSAE-b/l 5/15/11 ONJ 1963940SAEs-l 5/15/11 hemolysis 1094914

5/15/11 hemolysis(FU)11306455/15/11 cogn disturb(FU)11684335/15/11 neoplasm(FU) 1384682

25

Condensed List of CALGB Audit Updates Revised 2/15/125/15/11 ischemic colitis(FU)1518659

4. er 7/15/11 CFSAE-l 7/15/11 cardiac arrest 1932440SAE-l/b 8/15/11 choroidal eff 1800822SAE-l 8/15/11 AML 19211835.fb 9/15/11 Rx, CF

(Cont)50803 (Cont)

SAE-l/b 9/15/11 multi-organ fail 15069306.fb 9/30/11 CF, CAEPR updateSAEs-l/b 10/15/11 multi-organ fail(FU)1506930

10/15/11 choroidal effus(FU)1800822Perm clos 9/30/11SAE-l 12/15/11 toxic optic neuropathy

Rpt #lenalidomide-117.er 1/15/12 editSAE-l 2/15/12 2nd ca Rpt #lenal-12(77 SAEs)

50901 act 7/15/111.er 2/15/12 Rx

50904 act 4/8/11SAE-b 4/15/11 ARDS(FU) 1762261 SAE-l/b 8/15/11 choroidal eff 1800822SAE-b/f 8/15/11 esophagitis 1033338SAE-b 8/15/11 typhlitis 1959720SAE-l/b 9/15/11 multi-organ fail 1506930SAE-b/f 9/15/11 esophagitis(FU)1033338SAEs-l/b 10/15/11 multi-organ fail(FU)1506930

10/15/11 choroidal effus(FU)18008221.er 2/15/12 CF, Elig,CAEPR update(8 SAEs)

59802 act 11/15/00 clos 11/1/011. 3/15/01 edit2. 8/15/11 end FU

59903 act 12/15/99 clos 12/15/071. 4/15/00 edit2. 6/15/00 Elig3. 8/15/00 edit4. 10/15/00 edit5. 3/15/01 edit6. 7/15/01 edit7. 11/15/01 edit8. 3/15/02 edit9. 4/15/03 Rx, Elig10. 5/15/03 edit11. 6/15/04 edit12. 10/15/04 Rx13. fb 12/15/04 CF14. fb 2/15/05 drug safety info15.er 6/15/05 edit16.er 3/15/06 editAct Ltr 3/15/07 PML17. fb 5/15/07 CF

59905 act 5/15/01 clos 6/15/061. 9/15/02 Elig, CF2. 2/15/03 Sc , CF3. 6/15/03 Sc , Elig4. 8/15/03 edit5. 12/15/03 Elig, CF6.er 5/15/10 edit

60301 act 10/15/04 clos 6/6/071. 1/15/05 Elig2. 3/15/05 editSAE 4/15/05(4/15/05) card ischemia/infarct3. 8/15/05 RxSAEs 9/15/05(9/15/05) 2nd malig-keratocanthoma

9/15/05(9/15/05) sinus brady4. 11/15/05 Sc , Δ ppt , CFSAEs 1/15/06(1/15/06) memory impair, limb edema,

abd pain, constipation1/15/06(1/15/06) cerebrovas ischemia, ↑ BP

SAE 3/15/06(3/15/06) DVT, PE5. 5/15/06 Sc Δ, CFSAEs 6/30/06(6/30/06) bronchopul hemorrhage

6/30/06(6/30/06) perf appendixAct Ltr 7/5/06 GI perf6. 7/15/06 CFSAE 7/15/06(7/15/06) ↑ BP, RPLSSAEs-s 3/15/07(3/15/07) GI perf-jejunum

3/15/07(3/15/07) ↑ BP, intracran hem, somnolenceSae-S 3/15/07(3/15/07) CNS hemSuspension 4/5/07SAE-s 5/15/07(5/15/07) vomiting, perf ileumSAEs-s 6/15/07 colon perf

6/15/07 ↑ BP, intracran hem,somnolenceSAEs-s 6/15/07 abd pain, duodenal perfSAE-s 7/15/07 LV sys dysfxSAE-b/s 12/15/07 card ischemia/infarctSAE-s/e 1/15/08 colon perfSAE-s 1/15/08 CNS hemorrhageSAE-s/s 2/15/08 cerebrovascular ischemiaSAE-s/s 4/15/08 renal failSAEs-s 7/15/08 sudden death

7/15/08 sudden deathSAE-s/s 8/15/08 stomach hemorrhageSAEs-s 8/15/08 cardiac ischemia/infarction

8/15/08 sm bowel fistula & obstSAE-s/b 10/15/08 sudden deathSAE-s/t 10/15/08 sudden deathSAEs-s 11/15/08 ↑ lipase, ↑ amylase, abd

pain, pancreatitisSAEs-s 11/15/08 ↑ lipase, ↑ amylase, abd

pain, pancreatitisSAE-b/s 12/15/08 intracerebral hemorrhage7. er 2/15/09 CF (Action Letter)SAE-s 2/15/09 cardiac ischemia (FU)SAE-s/s 2/15/09 thrombosis, chest painSAE-s/s 3/15/09 thrombosis PE (FU)SAE-s/s 4/15/09 proteinuria, ↓ hgbSAE-s/s 12/1/09 proteinuria,↓hgb(FU)1704399SAE-s/s 2/15/10 PE 1222406(38 SAEs)

70004 act 6/15/01 clos 11/1/061. 7/15/01 edit2. 9/15/01 edit3. 12/15/01 edit4. 8/15/02 edit5. 1/15/03 edit6. 5/15/03 edit7. 2/15/04 Sc Δ, Elig, CF

26

Condensed List of CALGB Audit Updates Revised 2/15/128. 2/15/04 edit9. 5/15/04 Elig, CF10. 11/15/06 CF + spec bank2nd step closure 3/5/0711. er 1/15/07 edit12. er 8/15/07 CF, Δ ppts13.fb 1/15/09 CF

70301 act 10/15/05 clos 7/30/101. 3/15/06 CF2. 10/15/06 CF, Sc , ↑ ppt3. 4/15/07 edit4. er 6/15/08 Sc Closure 7/30/10

70305 act 6/30/061. 2/15/07 Elig, CF2. fb 9/15/07 Elig, CF3. er 3/15/08 Δ ppts4.er 12/15/08 Elig, CF5.er 4/1/09 Δ ppts6.er 7/15/09 Δ ppts7.er 9/15/10 Add/Limited Access Site8.er 4/15/11 ppt

70501 act 12/15/06 clos 8/11/111.er 6/15/07 edit, ppt2.fb 7/15/08 Sc ,Elig,Rx,CF3.er 4/17/09 ppt4.er 9/15/09 CF5.er 10/15/09 edit6.fb 1/15/11 Sc , CFPerm clos 8/11/11

70604 act 3/15/091.fb 1/15/11 Sc , Rx, CF2. er 2/15/11 edit2. er 2/17/11 correction3.fb 7/15/11 ppt, Rx, CF4.fb 12/15/11 Sc , CF

70806 act 10/15/101.er 1/15/11 edit2.fb 7/15/11 ppt, Elig, Sc , CF3.fb 2/15/12 ppt, Elig, Sc , CF

70807 act 12/1/101.fb 1/15/11 Sc , Elig2.fb 6/15/11 CF3.fb 6/15/11 CF,Elig, sub-study 151105 4.er 12/15/11 edit5.er 1/15/12 edit

79803 act 11/15/00 clos 11/5/091. 12/15/01 Sc ,Elig, CF2. 6/15/03 Sc ,Elig, CF3. 7/15/04 Sc , CF4. 7/15/04 edit5. 12/15/04 edit6. fb 4/15/07 Sc Δ, Elig, CF7. er 7/15/07 edit8. er 1/15/08 edit9. fb 1/15/08 CF10. er 3/15/08 edit11.er 8/15/08 Elig12.er 1/15/09 editPerm Clos 11/5/09

79806 act 2/15/00 clos 6/5/061. 6/15/00 edit2. 4/15/01 edit3. 11/15/01 Δ ppt4. 12/15/01 edit5. 1/15/02 Δ ppt6. 3/15/02 Δ ppt7. 7/15/02 Δ pptTemp closure 1/6/03

79809 act 12/15/01 clos 2/28/061. 2/15/03 Sc , Rx, Elig, CF2. 11/15/03 Sc , CF3. 6/15/04 Elig, CFNCI Ltr 9/15/04 ostenonecrosis of jaw4. 4/15/06 editSAE 6/30/06(6/30/06) ostenonecrosis of jaw5. 2/15/07 edit6. 5/15/07 editSAE-z 7/15/07 polymyalgia rheumatic(2 SAEs)

80101 act 12/15/02 clos 5/29/091. 7/15/03 edit2. 9/15/03 edit3. 2/15/06 Rx, Sc ∆, Elig, CF4. 9/15/06 CF5.nr 4/15/07 CF Perm clos 5/29/096.nr 5/15/10 edit

80203 act 12/15/03 clos 1/15/05SAEs 3/15/04(3/15/04) PVCs/trigeminy

3/15/04(3/15/04) bronchiolitis obliteransw/organizing pneum/TB

3/15/04(3/15/04) petechiae/excoriation3/15/04(3/15/04) febrile ↓ cts/enteritis3/15/04(3/15/04) recurrent GI bld 2° to

duodenal ulcerSAEs 3/15/04(3/15/04) signs of inflammation/

pancreatitis/abd pain/astheniaSAEs 4/15/04(4/15/04) PVCs/trigeminy

4/15/04(4/15/04) hepatic failure/death4/15/04(4/15/04) colonic obst/bowel perf/

fecal peritonitis/sepsis/death4/15/04(4/15/04) onycholysis4/15/04(4/15/04) muscle cramps/↓ Ca++/↓ Mg

SAE 4/15/04(4/15/04) C diff -(+) diarrheaSAEs 5/15/04(5/15/04) ↓ gen condition/N/V/fever

5/15/04(5/15/04) migraine synd/fever/↑ wbc5/15/04(5/15/04) mult intra-abd abscesses

SAEs 5/15/04(5/15/04) ↓ Mg++

5/15/04(5/15/04) hemorrhagic diarrhea5/15/04(5/15/04) skin ulcer

SAEs 6/15/04(6/15/04) Sudeck’s atrophy/post-traumatic osteoporosis

6/15/04(6/15/04) skin fissures (FU)SAEs 6/15/04(6/15/04) interstitial pneumonitis

w/non-cardiogenic puledema, ↑ cardiac troponin

SAEs 7/15/04(7/15/04) HA w/N & VSAEs 7/15/04(7/15/04) resp insufficiency

27

Condensed List of CALGB Audit Updates Revised 2/15/127/15/04(7/15/04) dermal cyst (atheroma)

SAEs 8/15/04(8/15/04) hemolytic anemia8/15/04(8/15/04) confusion, halluncinations8/15/04(8/15/04) MI

(Cont)80203(Cont)

SAEs 8/15/04(8/15/04) thrombosis rt popliteal artery8/15/04(8/15/04) syncope, ataxia

SAEs 9/15/04(9/15/04) hemolytic anemia (FU)9/15/04(9/15/04) sm bowel obst9/15/04(9/15/04) thrombosis of SVC

SAEs 10/15/04(10/15/04) dermal cyst, atheroma (FU)10/15/04(10/15/04) SBO (FU)10/15/04(10/15/04) thrombosis of SVC (FU)10/15/04(10/15/04) carotid artery rupture →

subsequent CVASAE 10/15/04(10/15/04) herpes zoster

Act Ltr 11/11/04 VOD SAE 11/15/04(11/15/04) gastritis w/diarrhea, dehydrationSuspension 12/3/04SAEs 12/15/04(12/15/04) ↑ K, ↓ Na

12/15/04(12/15/04) gross hematuria12/15/04(12/15/04) bone pain 2° to spondylodiscitis

SAEs 12/15/04(12/15/04) allergic reaction assocw/card ischemia/infarct

12/15/04(12/15/04) fatal febrile ↓ cts12/15/04(12/15/04) purpura/petechiae12/15/04(12/15/04) PE

SAEs 12/15/04(12/15/04) HA, ocular abnormalities12/15/04(12/15/04) PE, thromb int jug vein + SVC

1. 1/15/05 CFSAEs 1/15/05(1/15/05) allergic reaction assoc

w/ card isch/infarct (FU)1/15/05(1/15/05) erythema

SAEs 2/15/05(2/15/05) narcolepsy2/15/05(2/15/05) ↑ INR2/15/05(2/15/05) cardiac ischemia/infarct,

SAEs 2/15/05(2/15/05) skin necrosis2/15/05(2/15/05) sudden death

Act Ltr 3/10/05 ↓Mg 2. 3/15/05 CFSAE 3/15/05(3/15/05) H/A, vision disturbances-

flashing lights/floaters3/15/05(3/15/05) met acidosis 2° to diarrhea/

dehydration,pancreatitisSAEs 4/15/05(4/15/05) Hep B infect

4/15/05(4/15/05) interstitial lung dis,mycobacterium avium-intracellulare complex infect

SAEs 4/15/05(4/15/05) bilat hemianopia4/15/05(4/15/05) LV dysf, dyspnea, ↑ troponin I

3. 5/15/05 CFAct Ltr 6/6/05 cardiac ischemia, LV dysf SAEs 6/15/05(6/15/05) v tach

6/15/05(6/15/05) resp fail, at fibSAEs 6/15/05(6/15/05) bilat lower ext pain

6/15/05(6/15/05) card ischemiaSAEs 7/15/05(7/15/05) card ischemia, ↑ card

troponin, LV sys dysfSAEs 7/15/05(7/15/05) ↑ card troponin, dyspnea,

card pain, card ischemia/ infarct, atrial fib

7/15/05(7/15/05) ↓ Na, ↓ KSAEs 8/15/05(8/15/05) pul fibrosis

8/15/05(8/15/05) colitisSAEs 8/15/05(8/15/05) stiff neck, HA,

confusion, photophobia

8/15/05(8/15/05) ARDS, acute exacerbation atrial fib

8/15/05(8/15/05) bilat lower ext pain (FU)4. 9/15/05 add toxicity (cetux)

(Cont)80203(Cont)

SAEs 9/15/05(9/15/05) febrile ↓ cts, enteritis (FU)9/15/05(9/15/05) popliteal vein thrombosis(FU)

SAEs 9/15/05(9/15/05) acute hypersensitivity react(FU)9/15/05(9/15/05) pul hemorrhage 9/15/05(9/15/05) pul infilt9/15/05(9/15/05) CHF, exacerbation of COPD,

pancytopenia, death d/t massive liver failure

9/15/05(9/15/05) wound healing 20 intentionSAEs 10/15/05(10/15/05) card failure

10/15/05(10/15/05) hypotensive shockSAE 10/15/05(10/15/05) ventricular arrhythmiaSAE 11/15/05(11/15/05) allergic react, anaphylactic shockMemo 11/15/05(11/15/05) Ppt letterSAEs 12/15/05(12/15/05) ↓ BP

12/15/05(12/15/05) CV collapse2/15/06(2/15/06) hemoptysis,epistaxis, pul hem2/15/06(2/15/06) death,diarrhea,card fail,

renal failSAEs 2/15/06(2/15/06) interstitial nephritis, elect

abn(↓ K & ↓Mg)SAEs 2/15/06(2/15/06) acute lung edemaSAEs 2/15/06(2/15/06) fatal colitis w/ necrosis of

ileum 20 to mesenteric infarctSAEs 3/15/06(3/15/06) ax venous thrombosis,

LE purpura & vasculitis3/15/06(3/15/06) ↑ bili, cholangitis, cholestasis3/15/06(3/15/06) at fib, ↓ BP, coagulopathy3/15/06(3/15/06) pancolitis3/15/06(3/15/06) pul hemorrhage, post-

obstruct, pneumoniaSAEs 4/15/06(4/15/06) interstitial pneumonitis

4/15/06(4/15/06) diarrhea, sepsis syndSAEs 4/15/06(4/15/06) ↓ Ca, neutropenic sepsis

4/15/06(4/15/06) perf bowel4/15/06(4/15/06) GI perf-colon

SAEs 6/30/06(6/30/06) interstitial pneumonitis6/30/06(6/30/06) hearing loss6/30/06(6/30/06) infected pneumatocele

SAE 6/30/06(6/30/06) resp fail, interstit pneumonitSAE 7/15/06(7/15/06) CNS hemorrhageSAE 10/15/06(10/16/06) ruptured ovarian cystSAEs 11/15/06(11/15/06) subq abscess

11/15/06(11/15/06) stomach & colon perf w/peritonitis

SAEs 12/15/06(12/15/06) bile duct stenosis12/15/06(12/15/06) GI necrosis, colon perf

5. 5/15/07 Sc∆SAE-c 5/15/07(5/15/07) hemiparesisSAE-c 8/15/07 duodenal ulcer w/hemSAE-c 9/15/07 GI perfSAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-c 12/15/07 hyperosmolar nonketotic comaSAEs-c 1/15/08 suspected epiderm necrolysis


2/15/08 hepatic cytolysisSAE-o 2/15/08 sudden deathSAE-b/c 3/15/08 leucocytoclastic angiitisSAEs-o 3/15/08 GI perf

28

Condensed List of CALGB Audit Updates Revised 2/15/123/15/08 hemolytic uremic synd

SAEs-c 4/15/08 bronchiolitis obliterans,resp insuff, fever

4/15/08 gastric perf4/15/08 Quincke’s edema

(Cont)80203(Cont)

SAE-b/c 5/15/08 ostenonecrosis of spineSAE-c 5/15/08 sepsis, pancytopenia,





9/15/08 portal vein thromb, splenomegaly, focal nodular hyperplasia

9/15/08 cataractSAE-c 10/15/08 bronch hemorrhageSAEs-c 11/15/08 dry eye synd

11/15/08 allergic alveolitisSAEs-c 12/15/08 nephropathy w/hematuria,

acute tubular injury, renal fail(FU)SAEs-c 12/15/08 dry eye synd(FU)

12/15/08 leukocytoclastic vasculitis12/15/08 brachial artery thrombosis

SAEs-c 12/15/08 pericardial eff12/15/08 hypovolemic shk, lactic acidosis

SAE-c 1/15/09 card failSAEs-c 2/15/09 ileus


SAE-c 2/15/09 tumor hemSAE-c 4/15/09 anastomotic insuffSAE-c 5/15/09 erythema multiforme


SAE-b/o 6/15/09 allergic reaction (FU)SAE-o 6/15/09 sclerosing cholangitisSAE-c 6/15/09 necrotizing fasciitisSAE-c 8/15/09 laryngeal necrosis

8/15/09 GE hem, mucosal inflamSAE-o 8/15/09 sclerosing cholangitis(FU)SAE-c 10/15/09 gastric hem 126


SAE-c 11/2/09 GI perf cetux-129SAE-e/c 3/15/10 asteatotic eczema (FU)

1670060 (167 SAEs)

80302 act 2/15/06 clos 8/4/111. 9/15/06 edit2. er 11/15/06 CF3. fb 6/15/07 CFSuspension 9/6/074. fb 10/15/07 CF, Sc∆Reactivation 10/15/075.fb 12/15/08 CF, Sc∆6.er 5/15/10 Elig, Sc∆7.er 9/15/10 Add/Limited Access Site8.er 12/15/10 CTCAE version chgPerm clos 8/4/11

80303 act 6/15/04 clos 4/14/06Act Ltr 8/17/04 CV events 1. 11/15/04 Elig, CFSAE 11/15/04(11/15/04) arachnoiditis/

meningismus/radiculitisSAE 3/15/05(3/15/05) left retinal vein occlusionSAE 5/15/05(5/15/05) seizureSAEs 6/15/05(6/15/05) DIC

6/15/05(6/15/05) intestinal necrosis, perf2. 7/15/05 CF3. 7/15/05 editSAEs 8/15/05(8/15/05) sudden death

8/15/05(8/15/05) resp failure, pul ↑ BP,hypoxia, ↑ card troponin T

SAE 9/15/05(9/15/05) resp. fail, pul hypertensionAct Ltr 10/13/05 GI perfSAEs 10/15/05(10/15/05) hypoxia

10/15/05(10/15/05) GI perf w/ abd painSAE 10/15/05(10/15/05) hemoptysisSAE 11/15/05(11/15/05) vent fib, L vent

sys dysf, card ischemia4. 12/15/05 editSAEs 12/15/05(12/15/05) proteinuria, ↑ BP, renal fail

12/15/05(12/15/05) intracranial venous thrombosis, cerebrovasc ischemia

SAEs 1/15/06(1/15/06) thrombotic microangiopathy, proteinuria

SAEs 1/15/06(1/15/06) soft tiss necrosis/necrotizing fasciitis, infect

SAE 1/15/06(1/15/06) abd hemorrhage, biliary perf, necrotizing pancreatitis

SAE 2/15/06(2/15/06) hemoptysisAct Ltr 4/3/06(3/27/06) PRES/RPLSSAE 5/15/06(5/15/06) pul hemorrhageAct Ltr 6/27/06 DSMB results5. 6/30/06 CFSAEs 6/30/06(6/30/06) pul ↑ BP

6/30/06(6/30/06) bronchopul hemorrhage6/30/06(6/30/06) perf appendix

SAE 8/15/06(8/15/06) ↓ Ca, thrombotic, ↑ Crt, ↓ Namicroangiopath, ↓ fibrinogen, renal fail

6.er 11/15/06 Elig, Rx, CF, AEs7.nr 11/15/06 editSAEs 11/15/06(11/15/06) subq abscess

11/15/06(11/15/06) stomach & colon perf w/peritonit

SAE 12/15/06(12/15/06) intracranial hem,SAE 1/15/07(1/15/07) thromb microangiopath, HUSSAEs-b 2/15/07(2/15/07) seizure

2/15/07(2/15/07) neutropenia, pneumoniaSAEs-b 4/15/07(4/15/07) metabolic acidosis, drowsinessSAEs-b 4/15/07(4/15/07) tracheal injury(lacerat/infarct)

4/15/07(4/15/07) cellulitisSAE-b 4/15/07(4/15/07) tracheoesophageal fistula8. nr 5/15/07 editSAEs-b 6/15/07 tracheitis FU

6/15/07 hepatic cirrhosisSAEs-b 7/15/07 CSF leak, intracranial ↓ BP

7/15/07 soft tiss necrosis of neckSAEs-b 8/15/07 hydropneumothoraxSAEs-b 9/15/07 death, ↓ wbc, ↓ plts,

29

Condensed List of CALGB Audit Updates Revised 2/15/12metabolic acidosis

9. er 10/15/07 Sc∆SAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-b 11/15/07 encephalitis

(Cont)80303(Cont)

SAEs-b 12/15/07 hepatic cirrhosis12/15/07 ITP

SAE-b/s 12/15/07 card ischemia/infarctSAEs-b 1/15/08 ↑ Na+



2/15/08 acute renal failureSAEs-b/s 2/15/08 lactic acidosis, bowel ischemia



SAE-b/c 3/15/08 leucocytoclastic angiitisSAE-b/s 3/15/08 hemolysis (Revised)SAEs-b 5/15/08 necrotizing fasciitis


SAE-b/c 5/15/08 osteonecrosis of spineSAEs-b 6/15/08 lung collapse, tumor necrosis, SAEs-b 6/15/08 tumor necrosis, pul hem,

pneumothoraxSAEs-b 6/15/08 renal fail, proteinuria,

↓plts , ↓ANCSAE-b/c 6/15/08 osteonecrosis of spineSAEs-b 8/15/08 hydrocephalus




SAE-b/v 10/15/08 sudden deathbronchopleural fistula

SAEs-b 10/15/08 sudden death 10/15/08 non-infectious ext otitis

w/tympanic perf-FU10/15/08 sudden death

SAE-s/b 10/15/08 sudden deathSAEs-b 11/15/08 ARDS

11/15/08 sudden death11/15/08 sudden death11/15/08 fat necrosis11/15/08 cerebellar synd


12/15/08 ↓Mg 12/15/08 death

SAEs-b 12/15/08 ARDS(FU)12/15/08 PE12/15/08 rash, lower ext pain

SAEs-b 12/15/08 MDS12/15/08 death from unk cause


1/15/09 sudden death(FU)

1/15/09 fat necrosis(FU)SAEs-b 1/15/09 myalgia, rash, lethargy(FU)

1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

(Cont)80303(Cont)



3/15/09 PRES3/15/09 death (FU)

SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓ BPSAE-b 4/15/09 pneumonitis/pul infilt,

pericard eff (FU)SAE-b 4/15/09 card troponin I, card


4/15/09 ONJSAE-b/t 5/15/09 dehydration(FU)SAE-b/l 5/15/09 pneumonitis/pul infilt,atrial fibSAE-b 5/15/09 sudden death



SAEs-b 6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis



w/seizure, ↑ Crt SAEs-b 6/15/09 hydronephrosis, kidney hem

6/15/09 hemolysisSAE-b/o 6/15/09 allergic reaction (FU)SAEs-b/t 6/15/09 pneumonitis/pulm infilt


7/15/09 ischemic colitis7/15/09 esophageal fistula (FU)7/15/09 N/V, HA, dizziness,confus,


7/15/09 spontaneous pneumothorax(FU)7/15/09 renal fail, req dialysis (FU)

SAE-b 7/15/09 ↑card troponin, ↑ CPK, card ischemia/infarct(FU)


SAEs-b 8/15/09 CNS hem(FU) 16875198/15/09 opportunistic infect

assoc w/lymphopenia(FU)SAEs-b 8/15/09 sudden death(FU)

8/15/09 pul hem, pneumonitis (FU)SAEs-b/t 8/15/09 death(FU)



30

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b 10/15/09 esoph strict 1279067

10/15/09 c pul arrest(FU)133381410/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915

(Cont)80303(Cont)








4/15/10 SBO 1236502SAE-b 4/15/10 colitis 1295253

4/15/10 death 13666724/15/10 asystole (FU) 14491904/15/10 ileus, SBO, ↓Na,

DIC 1544184SAE-b/l 4/15/10 pneumonitis 1277486SAE-b/t 4/15/10 dehydration 1561869













10/15/10 anal ulcer(FU) 136711410/15/10 dehydration (FU) 1561869

10/15/10 dehydration(FU) 167047310/15/10 rectal bleeding (FU) 1746507

SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 1645650

(Cont)80303(Cont)

SAEs-b 10/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502


11/1/10 sudden death 1584360SAE-b 12/1/10 osteonecrosis 1470711(231 SAEs)

80402 act 1/15/06 clos 3/21/071. 2/15/06 CF2. 4/15/06 CFSuspension 4/24/06Reactivation 5/25/063. 7/15/06 edit4. 8/15/06 edit5. 9/15/06 edit6. 11/15/06 editSuspension 1/30/07

80403 act 9/15/06 clos 5/1/09SAE 10/15/06(10/16/06) ruptured ovarian cyst1. 12/15/06 Sc∆, CFSAEs 12/15/06(12/15/06) bile duct stenosis

12/15/06(12/15/06) GI necrosis, colon perf2. 1/15/07 editSAE-c 5/15/07(5/15/07) hemiparesis3. fb 6/15/07 CFSAE-c 8/15/07 duodenal ulcer w/hemSAE-c 9/15/07 GI perfSAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-c 12/15/07 hyperosmolar nonketotic comaSAEs-c 1/15/08 suspected epidermal necrolysisSAE-c 1/15/08 leucocytoclastic vasculitisSAEs-c 2/15/08 suspected epiderm necrolysis

2/15/08 hepatic cytolysisSAE-o 2/15/08 sudden deathSAE-b/c 3/15/08 leucocytoclastic angiitisSAEs-o 3/15/08 GI perf

3/15/08 hemolytic uremic syndSAEs-c 4/15/08 bronchiolitis obliterans,

resp insuff, fever4/15/08 gastric perf

SAE-c 4/15/08 Quincke’s edemaSAE-b/c 5/15/08 osteonecrosis of spineSAE-c 5/15/08 sepsis, pancytopenia,

metabolic acidosis4. fb 5/15/08 CF, Elig5. fb 6/2/08 Δ pptsSAE-b/c 6/15/08 osteonecrosis of spineSAEs-c 6/15/08 esophageal obst, esophagitis




31

Condensed List of CALGB Audit Updates Revised 2/15/129/15/08 portal vein thrombosis,

splenomegaly, focal nodular hyperplasia

9/15/08 cataractSAE-c 10/15/08 bronch hemorrhage

(Cont)80403(Cont)

SAEs-c 11/15/08 dry eye synd11/15/08 allergic alveolitis

SAE-b/o 12/15/08 L vent systolic dysfSAEs-c 12/15/08 nephropathy w/hematuria, acute

tubular injury, renal fail(FU)12/15/08 dry eye synd(FU)12/15/08 leukocytoclastic vasculitis12/15/08 brachial artery thrombosis12/15/08 pericardial eff12/15/08 hypovolemic shock,

lactic acidosisSAE-c 1/15/09 card fail SAEs-c 2/15/09 ileus

2/15/09 cerebral hemorrhage2/15/09 CHF2/15/09 tumor hemorrhage

6.er 3/15/09 Rx,CFSAE-b/o 3/15/09 hypersensitivity reactionSAE-c 4/15/09 anastomotic insuffClosure 5/1/09SAE-c 5/15/09 erythema multiforme

5/15/09 cerebral hemorrhage5/15/09 R vent fail, pleural eff

SAE-b/o 6/15/09 allergic reaction (FU)SAE-o 6/15/09 sclerosing cholangitisSAE-c 6/15/09 necrotizing fasciitis7.er 7/15/09 otherSAE-c 8/15/09 laryngeal necrosis

8/15/09 GE hem, mucosal inflamSAE-o 8/15/09 sclerosing cholangitis(FU)SAE-c 10/15/09 gastric hem 126


SAE-c 11/2/09 GI perf cetux-129SAE-e/c 3/15/10 asteatotic eczema(FU1670060SAE-o 10/15/10 secondary leukemia 1060315 SAE-o 1/15/11 secondary leukemia(FU) 1060315

SAE-c 2/15/11 death Rpt #cetux – 1302/15/11 edema Rpt #cetux – 1312/15/11 interstitial pneumonitis

Rpt #cetux – 1322/15/11 peripheral arterial thrombosis

Rpt #cetuximab – 133 SAE-c 3/15/11 cardiac arrest


Rpt #cetux-135SAE-c 4/15/11 perf divertic

Rpt #cetux-136 SAEs-c 5/15/11 neutropenia 1409011


8.er 6/15/11 CTCAE version 4.0 conversion SAEs-c 7/15/11 acute kidney injury Rpt #cetux-139

7/15/11 TIA Rpt #cetux-1407/15/11 asterixis, deathRpt #cetux-141

SAE-c 8/15/11 septic shock Rpt #cetux-1428/15/11 laryngeal hem Rpt #cetux-143

SAE-c 10/15/11 stasis derm Rpt #cetux-144SAE-c 11/15/11 cerebral infarct Rpt #cetux-145

11/15/11 ↓mobility Rpt #cetux-146

SAE-c 12/15/11 cranial hem Rpt #cetux-147(82 SAEs)

80405 act 9/15/05 clos 3/1/12SAEs 9/15/05(9/15/05) pul hemorrhage

9/15/05(9/15/05) pul infilt9/15/05(9/15/05) CHF exacerbation of COPD,

pancytopenia, death d/t liver fail9/15/05(9/15/05) wound healing by 20 intention

SAEs 10/15/05(10/15/05) card failure10/15/05(10/15/05) hypotensive shock10/15/05(10/15/05) ventricular arrhythmia10/15/05(10/15/05) hypoxia10/15/05(10/15/05) GI perf w/ abd pain

SAE 10/15/05(10/15/05) hemoptysisSAEs 11/15/05(11/15/05) allergic react,anaphylactic shkSAE 11/15/05(11/15/05) vent fib, L. vent sys dysf,

card ischemiaSAEs 12/15/05(12/15/05) ↓ BP

12/15/05(12/15/05) CV collapse 12/15/05(12/15/05) proteinuria, ↑ BP, renal fail

SAEs 12/15/05(12/15/05) intracranial venous thrombosis, cerebrovasc ischemia

SAEs 1/15/06(1/15/06) thrombotic microangiopathy, proteinuria

SAEs 1/15/06(1/15/06) soft tiss necrosis/necrotizing fasciitis, infect

SAEs 1/15/06(1/15/06) abd hemorrhage, biliary perf, necrotizing pancreatitis

SAEs 2/15/06(2/15/06) hemoptysis 2/15/06(2/15/06) acute renal fail

2/15/06(2/15/06) hemoptysis,epistaxis, pul hemSAEs 2/15/06(2/15/06) death,diarrhea,card fail,

renal failSAEs 2/15/06(2/15/06) interstitial nephritis, elect abn

(↓ K & ↓Mg)2/15/06(2/15/06) acute lung edema2/15/06(2/15/06) fatal colitis w/ necrosis of

ileum 20 to mesenteric farctSAEs 3/15/06(3/15/06) ax venous thrombosis,

LE purpura & vasculitisSAEs 3/15/06(3/15/06) ↑ bili, cholangitis, cholestasisSAEs 3/15/06(3/15/06) at fib, ↓ BP, coagulopathy

3/15/06(3/15/06) pancolitis3/15/06(3/15/06) pul hemorrhage, post-

obstruct, pneumoniaSAEs 4/15/06(4/15/06) interstitial pneumonitis

4/15/06(4/15/06) diarrhea, sepsis syndSAE 4/15/06(4/15/06) ↓ Ca, neutropenic sepsisSAEs 4/15/06(4/15/06) perf bowel

4/15/06(4/15/06) GI perf-colonAct Ltr 4/3/06(3/27/06) PRES/RPLS1.er 4/15/06 editSAE 5/15/06(5/15/06) pul hemorrhage2.fb 6/30/06 Rx, Elig, CFSAEs 6/30/06(6/30/06) interstitial pneumonitis

6/30/06(6/30/06) hearing loss6/30/06(6/30/06) infected pneumatocele

SAEs 6/30/06(6/30/06) resp fail, interstitial pneumonitis 6/30/06(6/30/06) pul ↑ BP

6/30/06(6/30/06) bronchopul hemorrhageSAE 6/30/06(6/30/06) perf appendixSAE 7/15/06(7/15/06) CNS hemorrhageSAE 8/15/06(8/15/06) ↓Ca, thrombotic microangiopathy,

32

Condensed List of CALGB Audit Updates Revised 2/15/12 ↑Crt, ↓fibrinogen, renal fail, ↓Na

SAE 10/15/06(10/16/06) ruptured ovarian cystSAE 11/15/06(11/15/06) subq abscess


SAEs 12/15/06(12/15/06) bile duct stenosis(Cont)

80405(Cont)SAEs 12/15/06(12/15/06) GI necrosis, colon perf

12/15/06(12/15/06) intracranial hemSAE 1/15/07(1/15/07) thromb microangiopathy, HUSSAEs-b 2/15/07(2/15/07) seizure

2/15/07(2/15/07) neutropenia, pneumonia SAEs-b 4/15/07 met acidosis, drowsiness

4/15/07 tracheal injury4/15/07 cellulitis4/15/07 tracheoesophageal fistula

SAE-c 5/15/07(5/15/07) hemiparesisSAEs-b 6/15/07 tracheitis FU

6/15/07 hepatic cirrhosis3. fb 7/15/07 Sc , Elig, Rx, CFSAEs-b 7/15/07 CSF leak, intracranial ↓ BP

7/15/07 soft tiss necrosis of neckSAE-b 8/15/07 hydropneumothoraxSAE-c 8/15/07 duodenal ulcer w/hemSAE-c 9/15/07 GI perfSAEs-b 9/15/07 death, ↓ wbc, ↓ plts, SAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-b 11/15/07 encephalitisSAE-c 12/15/07 hyperosmolar nonketotic comaSAEs-b 12/15/07 hepatic cirrhosis



SAE-b/e 1/15/08 death(removed)SAEs-c 1/15/08 susp epidermal necrolysis


2/15/08 hepatic cytolysisSAE-o 2/15/08 sudden deathSAEs-b 2/15/08 ↑ Na+

2/15/08 acute renal failureSAEs-b/s 2/15/08 lactic acidosis, bowel ischemia

2/15/08 hemolysis4.fb 2/15/08 Sc Δ, CF, QoL closedSAEs-b 3/15/08 tracheomalacia


SAE-b/c 3/15/08 leucocytoclastic angiitisSAE-o 3/15/08 GI perf

3/15/08 hemolytic uremic syndSAE-b/s 3/15/08 hemolysis (Revised)SAEs-c 4/15/08 bronchiolitis obliterans,

resp insuff, feverSAEs-c 4/15/08 gastric perf

4/15/08 Quincke’s edemaSAEs-b 5/15/08 necrotizing fasciitis



metabolic acidosisSAEs-b 6/15/08 lung collapse, tumor necrosis,

bronchopleural fistula

SAEs-b 6/15/08 tumor necrosis, pul hemorrhage, pneumothorax

6/15/08 renal fail, proteinuria, ↓plts ,↓ANC

SAE-b/c 6/15/08 osteonecrosis of spineSAEs-c 6/15/08 esophageal obst, esophagitis

6/15/08 airway obst(Cont)

80405(Cont)Suspension 6/16/08Act Ltr 6/9/08 ASCO updateSAE-c 7/15/08 ingrown eyelashesSAEs-b 8/15/08 hydrocephalus

8/15/08 radiation retinopathySAEs-c 8/15/08 phimosis


SAE-c 8/15/08 ventricular arrhythmia5.fb 9/9/08 Sc , Elig, CFSAEs-b 9/15/08 ↓plts



SAEs-c 9/15/08 esophagitis9/15/08 portal vein thromb,splenomegaly,

focal nodular hyperplasia9/15/08 cataract



SAE-b 10/15/08 sudden deathSAE-s/b 10/15/08 sudden deathSAE-c 10/15/08 bronch hemorrhageReactivation 11/15/08SAEs-b 11/15/08 ARDS



SAE-b/e 11/15/08 pneumomediastinumSAE-b/r 11/15/08 hemoptysisSAEs-c 11/15/08 dry eye synd

11/15/08 allergic alveolitisSAE-b/o 12/15/08 L vent systolic dysfSAEs-b/t 12/15/08 L vent dysf

12/15/08 ↓Mg 12/15/08 death


SAE-b/s 12/15/08 intracerebral hemorrhageSAE-b/e 12/15/08 pneumomediastium(FU)SAEs-c 12/15/08 nephropathy w/hematuria,

acute tubular injury, renal fail(FU)

12/15/08 dry eye synd(FU)SAEs-c 12/15/08 leukocytoclastic vasculitis

12/15/08 brachial artery thrombosisSAEs-c 12/15/08 pericardial eff

12/15/08 hypovolemic shock, lactic acidosis

SAE-c 1/15/09 card failSAE-b/t 1/15/09 L vent dysf(FU)SAEs-b 1/15/09 pul infilt

33

Condensed List of CALGB Audit Updates Revised 2/15/121/15/09 sudden death(FU)

SAEs-b 1/15/09 fat necrosis(FU)1/15/09 myalgia, rash, lethargy(FU)

SAEs-b 1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

(Cont)80405(Cont)

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm arterial/R atrial

thrombi (FU)2/15/09 vertigo

SAE-b 2/15/09 BBBSAE-b/t 2/15/09 ↓Mg (FU)SAEs-c 2/15/09 ileus


SAE-c 2/15/09 tumor hemSAEs-b/t 3/15/09 dehydration

3/15/09 PRESSAE-b/t 3/15/09 death (FU)SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓ BPSAE-b 4/15/09 pneumonitis/pul infilt,



4/15/09 ONJSAE-c 4/15/09 anastomotic insuffSAE-b/t 5/15/09 dehydration(FU)SAE-b/l 5/15/09 pneumonitis/pul infilt,


5/15/09 pneumothoraxSAE-c 5/15/09 erythema multiforme



GI perf, GI abscess6/15/09 CNS hem6/15/09 opportunistic infect6/15/09 pneumonitis

SAEs-b 6/15/09 cardiopul arrest6/15/09 esophageal fistula6/15/09 CNS hem, seizure

SAEs-b 6/15/09 PE, rectal infect 6/15/09 leukoencephalopathy

w/seizure, ↑ Crt 6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis


6/15/09 sudden deathSAE-o 6/15/09 sclerosing cholangitisSAE-c 6/15/09 necrotizing fasciitisSAEs-b 7/15/09 ↓plts – poss ITP (FU)


SAEs-b 7/15/09 N/V, HA, dizziness,confus, dysphagia, subdurahematoma, acute CNS bleed

SAEs-b 7/15/09 spontan pneumothorax (FU)7/15/09 renal fail, req dialysis (FU)7/15/09 ↑ card troponin, ↑ CPK,

card ischemia/infarct(FU)


SAE-c 8/15/09 laryngeal necrosis8/15/09 GE hem, mucosal inflam

SAEs-b 8/15/09 CNS hem(FU)8/15/09 opportunistic infect

assoc w/lymphopenia(FU)

(Cont)80405(Cont)



SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAE-o 8/15/09 sclerosing cholangitis(FU)SAE-b 9/15/09 CNS hem(FU) 1687519SAEs-b 9/15/09 seizures(FU) 1833568

9/15/09 hydronephrosis(FU) 18367816.fb 9/15/09 Sc∆, Rx, CFSAEs-b 10/15/09 esoph strict 1279067



SAE-c 10/15/09 gastric hem 12610/15/09 nec vasculitis 12710/15/09 pulm fibrosis 128

SAE-c 11/2/09 GI perf 129SAE-b/i 11/2/09 death 1857033SAE-b 12/1/09 colitis(FU) 1202538SAE-b/t 12/1/09 pneu (FU) 1392926SAEs-b/s 12/1/09 microangiopathy 1613977

12/1/09 microangiopathy 1312527SAEs-b 12/1/09 microangiopathy 1474081

12/1/09 microangiopathy 1395393SAEs-b 12/15/09 sudden death 1184694

12/15/09 GI perf (FU) 119244012/15/09 confusion 1206408

SAE-b/i 12/15/09 death (FU) 1857033SAE-b/s 12/15/09 dis prog 1939558SAE-b/t 1/15/10 fatigue 1448075SAE-b/s 1/15/10 ↓ BP 1329500SAEs-b 2/15/10 sudden death 1070874

2/15/10 esophageal stricture, esophagitis (FU) 1279067

2/15/10 death 1858857SAE-b 2/15/10 hemoptysis 1901777SAE-b 3/15/10 death 1900407SAE-e/c 3/15/10 asteatotic eczema (FU)1670060SAEs-b 4/15/10 atrial fib 1003452

4/15/10 SBO 12365024/15/10 colitis 1295253

SAEs-b 4/15/10 death 13666724/15/10 asystole (FU) 14491904/15/10 ileus, SBO, ↓Na 1544184





34

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-b/s 5/15/10 MI 13295007.er 6/15/10 CF,CAEPR updateSAEs-b 6/15/10 cerebral edema 1138043


SAE-b/t 6/15/10 anal ulcer 1367114(Cont)

80405(Cont)8.er(RRA) 7/12/10 CF,elig, CAEPR update8. er 7/20/10 correctionSAEs-b 7/15/10 sudden death 1190366



9. er 8/15/10 Bev CAEPR update, CF10.nr 8/15/10 editSAE-b/i 8/15/10 cholecystitis 1035078SAE-b 8/15/10 sudden death 1070874(FU)





SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 1448848

SAEs-b 10/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502

SAE-b/l 10/15/10 ONJ 1963940SAE-o 10/15/10 secondary leukemia 1060315SAE-b/i 11/1/10 cholecystitis(FU) 1035078SAE-b 11/1/10 cardiac arrest(FU)1544184




SAE-o 1/15/11 secondary leukemia (FU)106031511. er 2/15/11 editSAE-c 2/15/11 death Rpt #cetux – 130

2/15/11 edema Rpt #cetux– 1312/15/11 interstitial pneumonitis

Rpt #cetux– 132SAE-c 2/15/11 peripheral arterial thrombosis

Rpt #cetux – 133SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 107520112. fb 3/15/11 Sc∆SAEs-b 3/15/11 atrial fib(FU2) 1003452


SAE-c 3/15/11 cardiac arrest


Rpt #cetux-135SAEs-b 4/15/11 LV syst dysf (FU) 1383388

4/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 1574705

(Cont)80405(Cont)

SAEs-b 4/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts(FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU) 1075201 SAE-c 4/15/11 perf divertic Rpt #cetux-136 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade13574335/15/11 sudden death(FU) 14429535/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32


SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940SAEs-c 5/15/11 neutropenia 1409011


SAEs-b 6/15/11 sudden death 11735626/15/11 pneumonitis(FU) 14837496/15/11 necrotizing fasciitis 16532476/15/11 sudden death(FU) 17066736/15/11 ARDS 1727423


SAEs-b 7/15/11 acute kidney inj 12266257/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 13352677/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)1653247

SAEs-b 7/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 17611917/15/11 death 1793638


SAE-b/v 7/15/11 syncope 1714540SAEs-c 7/15/11 acute kidney inj Rpt #cetux-139

7/15/11 TIA Rpt #cetux-1407/15/11 asterixis,death Rpt #cetux-141

SAEs-b 8/15/11 pulm hem 11504318/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synod 12582398/15/11 cardiac arrest 12687588/15/11 ascites 1471652

SAEs-b 8/15/11 resp fail(FU) 16456508/15/11 pneumonitis 16751888/15/11 death(FU) 1793638

SAE-b/s 8/15/11 death(FU) 1850786SAE-b/i 8/15/11 bronchial hem 1868649SAE-c 8/15/11 septic shock Rpt #cetux-142

8/15/11 laryngeal hem Rpt #cetux-143

35

Condensed List of CALGB Audit Updates Revised 2/15/12 SAEs-b 9/15/11 pulm hem(FU)1150431

9/15/11 cerebellar synd(FU)12582399/15/11 cardiac arrest(FU) 1268758


SAE-b/i 10/15/11 ↑BP 1059673(Cont)

80405 (Cont)SAE-c 10/15/11 stasis derm Rpt #cetux-144SAEs-b/i 11/15/11 ↑BP(FU) 1059673 SAE-b 11/15/11 AML(FU) 1178143


SAE-c 11/15/11 cerebral infarct Rpt #cetux-14511/15/11 ↓mobility Rpt #cetux-146

SAE-b 12/15/11 optic neurop 1301534SAE-c 12/15/11 cranial hem Rpt #cetux-14713.er(RRA)12/16/11 CF, CAEPR updateSAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955

Closure 2/15/12SAE-b 3/1/12 hydrocephalus 1512246

(423 SAEs)

80502 act 3/15/08 clos 5/14/10SAE-A 3/15/08 anemia, intracranial hem, deathSAEs-A 4/15/08 cardiac ischemia,

4/15/08 cardiac/heart pain, 4/15/08 lung fistula,lung infect

SAEs-A 5/15/08 lung fistula,lung infect5/15/08 intracardiac thrombosis5/15/08 pul art thrombosis

SAE-s 5/15/08 ↑BP, bilat, blindness1.fb 6/15/08 ∆ pptsSAEs-A 6/15/08 GI perf, pneum, sepsis synd

6/15/08 GI perf, ileus, sepsisSAEs-A 7/15/08 retinal hem,

7/15/08 DVT, rt arm & leg PESAE-A 8/15/08 hemSAE-A 9/15/08 pneumonia, sepsis2.er(RRA) 11/11/08 CFSAE-c 11/15/08 ↑BP, pul edemaSAE-A 1/15/09 pul edema(FU)SAEs-A 2/15/09 ↑troponin

2/15/09 L vent systolic dysfSAEs-A 3/15/09 inf vena cava thrombosis

3/15/09 inf mesenteric art thromb3/15/09 poss intestinal obst3/15/09 bowel perf

SAE-A 4/15/09 cerebral infarct, GI hem, infmesenteric art thromb (FU)

4/15/09 retinal vein occlusionSAE-A 4/15/09 mesenteric art thrombosisSAEs-A 7/15/09 neck infect, fistula,

osteonecrosis -hyoid boneSAEs-A 7/15/09 GI stoma leak

7/15/09 mesenteric art thrombosis (FU)7/15/09 subdural hematoma

Suspension 8/19/09SAEs-A 9/15/09 CNS hem 1004278

9/15/09 c pul arrest 1545105SAE-A 10/15/09 subdural hem 1193721

10/15/09 GI leak (FU) 170522310/15/09 card ischemia 1847830

SAE-A 11/2/09 neck infect(FU) 12360783.fb 11/2/09 Sc∆, Rx, CF, Elig

Reactivation 11/2/09SAEs-A 12/15/09 lung hem 1193109

12/15/09 intracran hem 1447408SAEs-A 1/15/10 cerebral hem 16

1/15/10 ret vein occl 17

(Cont)80502 (Cont)

SAEs-A 1/15/10 CNS hem (FU) 10042781/15/10 subdural hem(FU) 11937211/15/10 pulm hem 1690055

SAE-A 2/15/10 aphasia 10538692/15/10 CV, ischemia 11301152/15/10 RPLS (FU) 1447408

SAEs-A 3/15/10 ischemic colon Mfr Rpt 2009SE33498

3/15/10 rad-ind leukoencephalopathy Mfr Rpt 2009SE27715

3/15/10 pulm hem 1690055(FU)SAEs-A 4/15/10 aphasia, blurred vision(FU)

1053869 4/15/10 pulm hem(FU) 11931094/15/10 card ischemia(FU) 1847830

4.er 4/27/10 CF(Action Letter)Closure 5/14/10SAE-A 5/15/10 encephalopathy1469546 SAE-A 7/15/10 cereb ischemia(FU)1130115SAE-A 8/15/10 neutropenia 13067595.er 9/15/10 editSAE-A 9/15/10 encephalopathy(FU) 1469546

9/15/10 MFR Rpt 2009SE03195 SAE-A 11/1/10 stroke 1072154

11/1/10 neutropenia 1435439SAE-A 12/15/10 neutropenia(FU)1435439SAE-A 1/15/11 arterial thrombosis1743582SAE-A 2/15/11 pruritus 15849026.er 3/15/11 editSAE-A 3/15/11 hem Rpt #AZD – 21

3/15/11 duodenal hem Rpt #1147736/AZD & cilen

3/15/11 stroke(FU2) 14695463/15/11 pruritus(FU) 15849023/15/11 art thrombosis(FU)1743582

SAE-A 6/15/11 encephalopathy1327278(66 SAEs)

80603 act 11/15/06 clos 11/2/07SAEs 12/15/06(12/15/06) pul hemorrhage

12/15/06(12/15/06) myocarditisSAE-s 2/15/07(2/15/07) neuro deficitSAE-s 3/15/07(3/15/07) optic disc edemaSAE-s 4/15/07(4/15/07) rhabdomyolysisSAEs-s 6/15/07 myocarditis, hep insuff, encephal,

pneumonia, renal insuff6/15/07 diverticular perf

SAEs-s 7/15/07 LV sys dysfx7/15/07 soft tiss necrosis of neck7/15/07 thrombotic microangiopathy

1. fb 8/15/07 Elig, CFSAEs-s 8/15/07 rhabdomyolysis w/renal fail

8/15/07 LV sys dysf SAE-s 9/15/07 thrombotic microang,GI perfSAE-s 10/15/07 dysphagia, tracheoesop fistulaSAE-s 12/15/07 LV systolic & diastolic

dys fx, card ischemiaSAEs-b/s 2/15/08 lactic acidosis, bowel ischemia

2/15/08 hemolysis

36

Condensed List of CALGB Audit Updates Revised 2/15/122/15/08 hepatic failure

SAE-s/s 2/15/08 cerebrovascular ischemiaSAE-s 2/15/08 GI stoma hemorrhageSAE-b/s 3/15/08 hemolysis (Revised)SAEs-s 4/15/08 cellulitis

4/15/08 L vent systolic dysfSAE-s/s 4/15/08 renal fail

(Cont)80603 (Cont)

SAE-s 5/15/08 liver failSAE-s 6/15/08 poss freq of fistulasSAE-s 7/15/08 rectal fistulaSAE-s/s 8/15/08 stomach hemSAE-s 8/15/08 GI fistula, hypokalemiaSAEs-s 10/15/08 syst cap leak synd

10/15/08 hrt fail-FUSAE-s/s 2/15/09 thrombosis, chest painSAE-s/s 3/15/09 thrombosis PE (FU)SAE-s 4/15/09 pul hemorrhageSAE-s/s 4/15/09 proteinuria, ↓ hgbSAE-s 5/15/09 necrotizing pancreatitisSAE-s 7/15/09 muscle weakness, ↓pltsSAE-b/s 8/15/09 microangiopathy 1613977SAE-s 8/15/09 PE 1168499

8/15/09 pul hem 1140081SAE-b/s 12/1/09 microangiopathy 1613977


SAEs-s 12/1/09 weakness(FU) 149169412/1/09 GI hem 1920386

SAE-s/s 12/1/09 proteinuria(FU) 1704399SAE-b/s 12/15/09 disease prog 1939558SAE-b/s 1/15/10 ↓ BP 1329500SAE-s 1/15/10 PE (FU) 1168449SAE-s 2/15/10 sept shk 2009299939/sunit-7SAE-s/s 2/15/10 PE 1222406 SAE-b/s 4/15/10 disease prog(FU) 1939558 SAE-s 4/15/10 laryngeal edema 1274440

4/15/10 dilated intest loops 17333784/15/10 CV, ischemia 1788898

SAE-b/s 5/15/10 MI 1329500 SAE-s/s 5/15/10 PE(FU) 1222406

SAE-s 6/15/10 dilated intest loops(FU)1733378 SAE-s 7/15/10 cereb ischemia 1788898

7/15/10 hypoxia 1842265SAE-s 9/15/10 laryngeal edema(FU)1274440 SAE-s 10/15/10 CNS hemorrhage (FU) 1842265SAE-s 11/1/10 lung hem 1272083SAE-s/c 12/1/10 pneumonitis 1226140SAE-s/s 8/15/11 gastric perf 1279979(63 SAEs)

80701 act 10/15/10SAE-b 11/1/10 sudden death 1584360SAE-b 12/1/10 osteonecrosis 1470711SAEs-b 1/15/11 atrial fib(FU) 1003452

1/15/11 colitis(FU2) 12952531/15/11 LV systolic dysfx 13833881/15/11 sm bowel perf(FU) 14488481/15/11 sudden death (FU2) 14491901/15/11 ARDS 15137261/15/11 sudden death(FU) 15843601/15/11 cellulitis 1852653


SAEs-b 3/15/11 atrial fib(FU2) 10034523/15/11 pneumonitis/pulm infilt1483749

3/15/11 tinnitus 1897814SAEs-b 4/15/11 LV syst dysf(FU) 1383388

4/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 16592924/15/11 infection 1694292

(Cont)80701 (Cont)

SAEs-b 4/15/11 ↓plts(FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU)1075201 1.fb 5/15/11 CF, Elig, Rx, pptsSAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade1357433SAEs-b 5/15/11 sudden death(FU) 1442953

5/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32


SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940SAEs-b 6/15/11 sudden death 1173562

6/15/11 pneumonitis(FU)14837496/15/11 necrotizing fasciitis 1653247

SAEs-b 6/15/11 sudden death(FU)17066736/15/11 ARDS 1727423










11/15/11 ataxia Rpt#bev-34

37

Condensed List of CALGB Audit Updates Revised 2/15/1211/15/11 leukoenceph Rpt#bev-34


1/15/12 death 18540331/15/12 LV sys dysf 1988955

SAE-b 2/15/12 hydrocephalus 1512246(43 SAEs)

80702 act 6/15/10SAE-o 10/15/10 secondary leukemia 10603151.fb 11/1/10 Sc , Rx, CF, EligSAE-o 1/15/11 secondary leukemia(FU) 10603152.fb 7/15/11 ppt, Rx, Sc , Elig, CF(SAEs-2)

80802 act 2/15/10SAE-s/s 2/15/10 PE 1222406SAE-b/s 4/15/10 RPLS, ↑BP 1706912SAE-s/s 5/15/10 PE(FU) 1222406 1.er 6/15/10 CF, CAEPR updateSAE-s 6/15/10 adrenal insuff, 1170096SAE-s/t 6/15/10 pancreatitis 14161212.fb 9/15/10 Sc , Rx, CF, EligSAE-b/s 9/15/10 RPLS(FU) 1706912SAE-s 9/15/10 adrenal insuff 1170096(FU)SAE-s 1/15/11 sepsis 15465563.fb 4/15/11 Sc , Rx, CF, ppts, Elig, SAE-s 4/15/11 sepsis 1546556SAE-s/e 5/15/11 death 1688406SAE-b/s 6/15/11 death 1850786SAE-s/e 7/15/11 GI perf 1688406SAE-s 7/15/11 card arrest(FU1)1807371SAE-b/s 8/15/11 death(FU) 1850786SAE-s/s 8/15/11 gastric perf 1279979SAE-s/s 9/15/11 gastric perf(FU) 12799794.er 10/15/11 CFSAE-s 11/15/11 death 1224205SAE-s 12/15/11 death(FU) 1224205(18 SAEs)

80803 act 7/15/111.fb 1/15/12 Sc , CF, Rx, Elig

90202 act 1/15/041. 11/15/04 CF2. 4/1/05 CF3. fb 7/15/05 Rx, Elig, CF4. fb 1/15/06 Sc , CF, EligSAE 6/30/06(6/30/06) osteonecrosis of jaw5.fb 11/15/06 edit6. fb 4/15/07 CFSAE-z 7/15/07 polymyalgia rheumatica7. er 11/15/07 ppts8. er 10/15/10 edit9.er 12/15/10 CF, Elig(2 SAEs)

90203 act 12/15/061. fb 8/15/07 Elig2. er 3/15/08 other3.er 9/15/08 Elig4.er 9/15/10 ppt5.fb 7/15/11 ppt, Elig, CF

90206 act 10/1/03 clos 7/1/051. 11/15/03 editSAEs 12/15/03(12/15/03) hemoptysis

12/15/03(12/15/03) confusion, neuro ∆s12/15/03(12/15/03) serositis

SAE 2/15/04(2/15/04) resp fail/pneumothorax2. 3/15/04 editSAE 3/15/04(3/15/04) CVASAE 4/15/04(4/15/04) gastric variceal hemSAEs 6/15/04(6/15/04) pneumonitis/pul infilt

6/15/04(6/15/04) tremor & cerebellar synd3. 7/15/04 Sc Δ, Elig, CF

(IFN now supplied)Act Ltr 8/17/04 CV eventSAE 10/15/04(10/15/04) renal fail, amyloidosisSAE 11/15/04(11/15/04) arachnoiditis/

meningismus/radiculitis4. 12/15/04 Elig, CFSAE 3/15/05(3/15/05) left retinal vein occlusionSAE 4/15/05(4/15/05) ARDSSAE 5/15/05(5/15/05) seizureSAEs 6/15/05(6/15/05) disseminated intra vasc

coagulationSAE 6/15/05(6/15/05) intestinal necrosis, perfSAEs 6/15/05(6/15/05) confusion/hypoxia/acute

renal fail5. 6/15/05(6/15/05) CFSAEs 8/15/05(8/15/05) sudden death

8/15/05(8/15/05 resp failure, pul ↑ BP,hypoxia, ↑ card troponin

6.er 9/15/05 editSAE 9/15/05(9/15/05) resp fail, pul ↑ BPAct Ltr 10/4/05 GI perf SAEs 10/15/05(10/15/05) hypoxia

10/15/05(10/15/05) GI perf w/ abd painSAE 10/15/05(10/15/05) hemoptysisSAE 11/15/05(11/15/05) vent fib, L. vent

sys dysf, card ischemiaSAEs 12/15/05(12/15/05) proteinuria, ↑ BP, renal failSAEs 12/15/05(12/15/05) intracranial venous thrombisis,

cerebrovasc ischemiaSAEs 1/15/06(1/15/06) thromb microangiopathy,

proteinuriaSAEs 1/15/06(1/15/06) soft tiss necrosis/

necrotizing fasciitis, infectSAE 1/15/06(1/15/06) abd hem, biliary perf,

necrotizing pancreatitisSAE 2/15/06(2/15/06) hemoptysisAct Ltr 4/3/06(3/27/06) PRES/RPLSSAE 5/15/06(5/15/06) pul hemSAEs 6/30/06(6/30/06) pul ↑ BP

6/30/06(6/30/06) bronchopul hem6/30/06(6/30/06) perf appendix

SAE 8/15/06(8/15/06) ↓Ca, thrombotic microangiopathy, ↑Crt, ↓fibrinogen, renal fail, ↓Na

SAEs 11/15/06(11/15/06) subq abscess11/15/06(11/15/06) stomach & colon perf

w/peritonitisSAE 12/15/06(12/15/06) intracranial hem7.fb 1/15/07 Sc Δ, CF

38

Condensed List of CALGB Audit Updates Revised 2/15/12SAE 1/15/07(1/15/07) thrombotic

microangiopathy, HUSSAEs-b 2/15/07(2/15/07) seizure

2/15/07(2/15/07) neutropenia, pneumoniaSAEs-b 4/15/07(4/15/07) metabolic acidosis, drowsiness

4/15/07(4/15/07) tracheal injury (laceration or infarction)

(Cont)90206 (Cont)

SAEs-b 4/15/07(4/15/07) cellulitis4/15/07(4/15/07) tracheoesophageal fistula

8.nr 6/15/07 editSAEs-b 6/15/07 tracheitis


7/15/07 soft tiss necrosis of neck9. fb 8/15/07 release drug dataSAE-b 8/15/07 hydropneumothoraxSAEs-b 9/15/07 death, ↓ wbc, ↓ plts,

metabolic acidosisSAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-b 11/15/07 encephalitisSAEs-b 12/15/07 hepatic cirrhosis




2/15/08 acute renal failureSAEs-b/s 2/15/08 lactic acidosis, bowel

ischemia2/15/08 hemolysis

SAEs-b 3/15/08 tracheomalacia3/15/08 tumor ulceration in breast

SAe-b 3/15/08 CNS tumor necrosisSAE-b/c 3/15/08 leucocytoclastic angiitisSAE-b/s 3/15/08 hemolysis (Revised)SAEs-b 5/15/08 necrotizing fasciitis



bronchopleural fistulaSAEs-b 6/15/08 tumor necrosis, pul hem,

pneumothorax6/15/08 renal fail, proteinuria,

↓plts ,↓ANCSAE-b/c 6/15/08 osteonecrosis of spineSAEs-b 8/15/08 hydrocephalus






10/15/08 sudden deathSAE-s/b 10/15/08 sudden deathSAEs-b 11/15/08 ARDS

11/15/08 sudden death11/15/08 sudden death11/15/08 fat necrosis

SAE-b 11/15/08 cerebellar syndSAE-b/e 11/15/08 pneumomediastinumSAE-b/r 11/15/08 hemoptysisSAE-b/o 12/15/08 L vent systolic dysfSAEs-b/t 12/15/08 L vent dysf

12/15/08 ↓Mg 12/15/08 death

(Cont)90206 (Cont)

SAEs-b 12/15/08 ARDS(FU)12/15/08 PE

SAEs-b 12/15/08 rash, lower ext pain12/15/08 MDS12/15/08 death from unk cause


1/15/09 sudden death(FU)1/15/09 fat necrosis(FU)

SAEs-b 1/15/09 myalgia, rash, lethargy(FU)1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail

SAEs-b 2/15/09 somnolence, sudden death2/15/09 pulm art/R atrial thrombi (FU)

SAEs-b 2/15/09 vertigo2/15/09 BBB


3/15/09 PRES3/15/09 death (FU)

SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓ BPSAE-b 4/15/09 pneumonitis/pul infilt,



4/15/09 ONJSAE-b/t 5/15/09 dehydration(FU)SAE-b/l 5/15/09 pneumonitis/pul infilt,




SAEs-b 6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis6/15/09 cardiopul arrest

SAEs-b 6/15/09 esophageal fistula6/15/09 CNS hemorrhage, seizure6/15/09 PE, rectal infect

6/15/09 leukoencephalopathy w/seizure, ↑ Crt

SAEs-b 6/15/09 hydronephrosis, kidney hem6/15/09 hemolysis




SAEs-b 7/15/09 N/V, HA, dizziness,confus, dysphagia, subdural hematoma, acute CNS bleed

7/15/09 spontan pneumothorax (FU)

39

Condensed List of CALGB Audit Updates Revised 2/15/12SAEs-b 7/15/09 renal fail, req dialysis (FU)

7/15/09 ↑ card troponin, ↑ CPK, card ischemia/infarct(FU)


(Cont)90206 (Cont)

SAEs-b 8/15/09 CNS hemorrhage(FU)8/15/09 opportunistic infect

assoc w/lymphopenia(FU)8/15/09 sudden death(FU)

SAEs-b 8/15/09 pul hem, pneumonitis (FU)SAEs-b/t 8/15/09 death(FU)



SAEs-b 10/15/09 esoph strict 127906710/15/09 c pul arrest(FU)1333814

SAEs-b 10/15/09 PE(FU) 141914410/15/09 hemolysis(FU) 1950915



12/1/09 microangiopathy 131252712/1/09 microangiopathy 1474081

SAE-b/s 12/1/09 microangiopathy 139539310.er 12/15/09 otherSAEs-b 12/15/09 sudden death 1184694

12/15/09 GI perf(FU) 119244012/15/09 confusion 1206408


2/15/10 esophageal strict, esophagitis (FU) 1279067

2/15/10 death 18588572/15/10 hemoptysis 1901777


4/15/10 SBO 12365024/15/10 colitis 12952534/15/10 death 1366672

SAEs-b 4/15/10 asystole (FU) 14491904/15/10 ileus, SBO, ↓Na 1544184


4/15/10 rectal pain, anal fistula 1671222SAE-b/t 4/15/10 dehydration (FU) 1710309 SAE-b/s 4/15/10 RPLS, ↑BP 1706912SAE-b/sun 4/15/10 disease prog (FU) 1939558 SAEs-b/t 5/15/10 renal fail 1220746






(Cont)90206 (Cont)




SAE-b/t 8/15/10 rectal pain 1671222(FU)11.er 9/15/10 pptSAE-b 9/15/10 cerebral edema(FU)1138043



SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 1712748

SAEs-b 10/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502





SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 107520112.er 3/15/11 Sc , ppt


SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 1574705

SAEs-b 4/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts (FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU) 1075201

SAEs-b 5/15/11 death 12505015/15/11 pericard tamponade13574335/15/11 sudden death(FU)14429535/15/11 sepsis 1523186

40

Condensed List of CALGB Audit Updates Revised 2/15/125/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32

(Cont)90206 (Cont)





SAEs-b 7/15/11 acute kidney inj 12266257/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 13352677/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)16532477/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 1761191

SAE-b 7/15/11 death 1793638SAEs-b/t 7/15/11 anal fissure(FU1)1345682

7/15/11 resp fail 1860656SAE-b/v 7/15/11 syncope 1714540SAEs-b 8/15/11 pulm hem 1150431


SAE-b/s 8/15/11 death(FU) 1850786SAE-b/i 8/15/11 bronchial hem 1868649SAEs-b 9/15/11 pulm hem(FU)1150431

9/15/11 cerebellar synd(FU)12582399/15/11 cardiac arrest(FU) 1268758




SAE-b 12/15/11 optic neurop 130153413.er(RRA)12/16/11 CF, CAEPR updateSAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955


90401 act 4/15/05 clos 12/21/07SAE 5/15/05(5/15/05) seizureSAEs 6/15/05(6/15/05) DIC

6/15/05(6/15/05) intestinal necrosis, perfSAEs 8/15/05(8/15/05) sudden death

8/15/05(8/15/05) resp fail, pul,↑BP, hypoxia, ↑card, troponin T

SAE 9/15/05(9/15/05) resp fail, pul ↑ BP

Act Ltr 10/13/05 GI perf SAEs 10/15/05(10/15/05) hypoxia

10/15/05(10/15/05) GI perf w/ abd pain10/15/05(10/15/05) hemoptysis

1. er 10/15/05 CF(NA)SAE 11/15/05(11/15/05) vent fib, L. vent

sys dysf, card ischemia(Cont)

90401(Cont)SAEs 12/15/05(12/15/05) proteinuria, ↑ BP, renal failSAEs 12/15/05(12/15/05) intracranial venous thrombosis,

cerebrovasc ischemiaSAEs 1/15/06(1/15/06) abd hem,biliary perf,

necrotizing pancreatitisSAEs 1/15/06(1/15/06) thrombotic microangiopathy,

proteinuriaSAEs 1/15/06(1/15/06) soft tiss necrosis/

necrotizing fasciitis, infectSAE 2/15/06(2/15/06) hemoptysisAct Ltr 4/3/06 PRESSAE 5/15/06(5/15/06) pul hemSAEs 6/30/06(6/30/06) pul ↑ BP

6/30/06(6/30/06) bronchopul hem6/30/06(6/30/06) perf appendix

2. fb 8/15/06 Sc , Elig, Rx, CFSAE 8/15/06(8/15/06) ↓Ca, thrombotic microangiopathy,

↑Crt, ↓fibrinogen, renal fail, ↓NaSAE 11/15/06(11/15/06) subq abscess


SAE 12/15/06(12/15/06) intracranial hemSAE 1/15/07(1/15/07 thromb microangiopath, HUSSAEs-b 2/15/07(2/15/07) seizure

2/15/07(2/15/07) neutropenia, pneumoniaSAEs-b 4/15/07(4/15/07) metabolic acidosis, drowsiness

4/15/07(4/15/07) tracheal inj (laceration/or infarct)4/15/07(4/15/07) cellulitis

SAE-b 4/15/07(4/15/07) tracheoesophageal fistulaSAEs-b 6/15/07 tracheitis


7/15/07 soft tiss necrosis of neckDSMB 7/23/07 recommendations SAE-b 8/15/07 hydropneumothoraxSAEs-b 9/15/07 death, ↓ wbc, ↓ plts,

metabolic acidosis3. fb 10/15/07 Rx, Elig, CFSAE-b/o 11/15/07 lower GI hem, rectal perf,

rectal leak, pelvic abscessSAE-b 11/15/07 encephalitisSAEs-b 12/15/07 hepatic cirrhosis




2/15/08 acute renal failureSAEs-b/s 2/15/08 lactic acidosis, bowel ischem



SAE-b/c 3/15/08 leucocytoclastic angiitisSAE-b/s 3/15/08 hemolysis (Revised)SAEs-b 5/15/08 necrotizing fasciitis

5/15/08 thrombocytopenia

41

Condensed List of CALGB Audit Updates Revised 2/15/125/15/08 cognitive & MRI∆


bronchopleural fistulaSAEs-b 6/15/08 tum necr, pul hem, pneumothorax

6/15/08 renal fail, proteinuria, ↓plts,↓ANCSAE-b/c 6/15/08 osteonecrosis of spine

(Cont)90401(Cont)

SAEs-b 8/15/08 hydrocephalus8/15/08 radiation retinopathy

SAEs-b 9/15/08 ↓plts9/15/08 non-infectious ext otitis

w/tympanic perfSAEs-b/e 9/15/08 blurred vision

9/15/08 MDSSAE-b/v 10/15/08 sudden deathSAEs-b 10/15/08 sudden death


SAEs-b 10/15/08 sudden deathSAE-s/b 10/15/08 sudden deathSAEs-b 11/15/08 ARDS




12/15/08 ↓Mg SAE-b/t 12/15/08 deathSAEs-b 12/15/08 ARDS(FU)

12/15/08 PE12/15/08 rash, lower ext pain12/15/08 MDS12/15/08 death from unk cause

SAE-b/s 12/15/08 intracerebral hemorrhageSAE-b/e 12/15/08 pneumomediastium(FU)SAE-b/t 1/15/09 LV dysf(FU)SAEs-b 1/15/09 pul infilt

1/15/09 sudden death(FU)1/15/09 fat necrosis(FU)

SAEs-b 1/15/09 myalgia, rash, lethargy(FU)1/15/09 cerebellar synd(FU)1/15/09 ↑ K, ↑ Crt, renal fail



3/15/09 PRES3/15/09 death (FU)

SAE-b/o 3/15/09 hypersensitivity reactionSAE-b 3/15/09 liver fail, L vent dysf, ↓BP(FU)SAE-b 4/15/09 pneumonitis/pul infilt,




5/15/09 pneumothorax4.er 5/15/09 Sc


GI perf, GI abscess6/15/09 CNS hemorrhage6/15/09 opportunistic infect6/15/09 pneumonitis

(Cont)90401(Cont)


SAEs-b 6/15/09 hydronephrosis, kidney hem6/15/09 PE, rectal infect6/15/09 hemolysis6/15/09 leukoencephalopathy

w/seizure, ↑ Crt SAE-b/o 6/15/09 allergic reaction (FU)SAEs-b/t 6/15/09 pneumonitis/pulm infilt


7/15/09 ischemic colitis7/15/09 esophageal fistula (FU)7/15/09 spontan pneumothorax (FU)

SAEs-b 7/15/09 N/V, HA, dizziness,confus, dysphagia, subdural ematoma, acute CNS bleed

SAEs-b 7/15/09 renal fail, req dialysis (FU)7/15/09 ↑ card troponin, ↑ CPK,




8/15/09 sudden death(FU)8/15/09 pul hem, pneumonitis (FU)


SAE-b/s 8/15/09 thrombotic microangiopathySAE-b/i 8/15/09 seizureSAEs-b 9/15/09 CNS hem(FU) 1687519SAEs-b 9/15/09 seizures(FU) 1833568

9/15/09 hydronephrosis 1836781SAEs-b 10/15/09 esoph strict 1279067




12/1/09 microangiopathy 1312527SAEs-b/s 12/1/09 microangiopathy 1474081

12/1/09 microangiopathy 1395393SAEs-b 12/15/09 sudden death 1184694

12/15/09 GI perf(FU) 119244012/15/09 confusion 1206408



42

Condensed List of CALGB Audit Updates Revised 2/15/12SAE-b 3/15/10 death 1900407SAEs-b 4/15/10 atrial fib 1003452



(Cont)90401(Cont)




5/15/10 LV dysf 12495185/15/10 dehydration 1670473

SAE-b/t 5/15/10 rectal hem 1746507SAE-b/s 5/15/10 MI 1329500SAEs-b 6/15/10 cerebral edema 1138043








9/15/10 death(FU) 1900497SAE-b/s 9/15/10 RPLS(FU) 1706912

SAEs-b/t 10/15/10 renal fail(FU) 122074610/15/10 anal ulcer(FU) 136711410/15/10 dehydration (FU) 156186910/15/10 dehydration(FU) 167047310/15/10 rectal bleeding (FU) 1746507


SAEs-b 10/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU)236502





SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 1075201SAEs-b 3/15/11 atrial fib(FU2) 1003452


SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 1659292

(Cont)90401(Cont)

SAEs-b 4/15/11 infection 16942924/15/11 ↓plts (FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU) 1075201SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade13574335/15/11 sudden death(FU) 14429535/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 1751032

SAEs-b 5/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32


SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940



SAEs-b 7/15/11 acute kidney inj 12266257/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 1335267

SAEs-b 7/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)16532477/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 17611917/15/11 death 1793638








11/15/11 ataxia Rpt#bev-34

43

Condensed List of CALGB Audit Updates Revised 2/15/1211/15/11 leukoenceph Rpt#bev-34

SAE-b 12/15/11 optic neurop 1301534SAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955


90601 act 7/15/09SAEs-b 7/15/09 ↓plts – poss ITP (FU)

7/15/09 ischemic colitis7/15/09 esophageal fistula (FU)7/15/09 N/V, HA, dizziness,confus,

SAEs-b 7/15/09 spontan pneumothorax (FU)7/15/09 renal fail, req dialysis (FU)7/15/09 ↑ card troponin, ↑ CPK (FU)


SAEs-b 8/15/09 CNS hemorrhage(FU)8/15/09 opport infect ssocw/lymph(FU)8/15/09 sudden death(FU)

SAE-b 8/15/09 pul hem, pneumonitis (FU)SAEs-b/t 8/15/09 death(FU)










1.er 3/15/10 Sc ΔSAE-b 3/15/10 death 1900407SAEs-b 4/15/10 atrial fib 1003452









(Cont)90601(Cont)

SAE-b 6/15/10 death (FU) 1366672 SAE-b/t 6/15/10 anal ulcer 1367114SAEs-b 7/15/10 sudden death 1190366





SAE-b/t 8/15/10 rectal pain 1671222(FU)2.er 9/15/10 CF, CAEPR updateSAE-b 9/15/10 cerebral edema(FU)1138043



SAEs-b 10/15/10 encephalopathy 122674510/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502



1/15/11 colitis (FU2) 12952531/15/11 LV systolic dysfx 13833881/15/11 sm bowel perf(FU) 14488481/15/11 sudden death (FU2) 1449190

SAEs-b 1/15/11 ARDS 1513726SAE-b 1/15/11 sudden death (FU) 1584360

1/15/11 cellulitis 1852653 SAE-b 2/15/11 encephalopathy (FU) 1226745SAE-b/t 2/15/11 duod-aortic fistula 10752013.fb 3/15/11 Sc , ppt, Rx,elig,CF4.er 3/15/11 editSAEs-b 3/15/11 atrial fib(FU2) 1003452


SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 1574705

SAEs-b 4/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts (FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

44

Condensed List of CALGB Audit Updates Revised 2/15/12 SAE-b/i 4/15/11 LV diastolic dysf 1892974

SAE-b/t 4/15/11 duodenal perf (FU)1075201 SAEs-b 5/15/11 death 1250501

5/15/11 pericard tamponade13574335/15/11 sudden death(FU) 14429535/15/11 sepsis 15231865/15/11 brach art thromb(FU) 1574705

(Cont)90601(Cont)

SAEs-b 5/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32



6/15/11 pneumonitis(FU)14837496/15/11 necrotizing fasciitis 16532476/15/11 sudden death(FU) 1706673

SAE-b 6/15/11 ARDS 1727423SAE-b/t 6/15/11 LV systolic dysf(FU)1792675 5.er 7/15/11 CFSAEs-b 7/15/11 acute kidney inj 1226625




8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synd 12582398/15/11 cardiac arrest 12687588/15/11 ascites 14716528/15/11 resp fail(FU) 1645650

SAE 8/15/11 pneumonitis 16751888/15/11 death(FU) 1793638







1/15/12 death 18540331/15/12 LV sys dysf 1988955

SAE-b 2/15/12 hydrocephalus 1512246 (SAEs-177)

90802 act 9/15/10SAEs-b 10/15/10 encephalopathy 1226745

10/15/10 small bowel perf 144884810/15/10 bladder infect 164565010/15/10 ARDS 165929210/15/10 thrombocytopenia 171274810/15/10 cerebritis 180348010/15/10 small bowel obst(FU) 1236502

SAE-b/l 10/15/10 ONJ 1963940SAE-b 11/1/10 sudden death 1584360

SAE-b 12/1/10 osteonecrosis 1470711SAEs-b 1/15/11 atrial fib (FU) 1003452





SAEs-b 4/15/11 LV syst dysf (FU) 13833884/15/11 sudden death 14429534/15/11 ARDS(FU) 1513726 4/15/11 brach art thrombosis 15747054/15/11 ARDS(FU) 16592924/15/11 infection 16942924/15/11 ↓plts (FU) 17127484/15/11 infect (FU) 18034804/15/11 necrot fasciitis (FU)18526534/15/11 tinnitus (FU) 1897814

SAE-b/i 4/15/11 LV diastolic dysf 1892974SAE-b/t 4/15/11 duodenal perf (FU)1075201

SAEs-b 5/15/11 death 12505015/15/11 pericard tamponade13574335/15/11 sudden death(FU) 1442953

SAEs-b 5/15/11 sepsis 15231865/15/11 brach art thromb(FU) 15747055/15/11 perit cav infect(FU) 16942925/15/11 sudden death 17066735/15/11 wound comp 17510325/15/11 death 17611915/15/11 herpes encephalitis Rpt -bev-32


SAE-b/i 5/15/11 LV diastolic dysf(FU)1892974SAE-b/l 5/15/11 ONJ 1963940


SAE-b/t 6/15/11 LV systolic dysf(FU)1792675 1.fb 7/15/11 ppt, CFSAEs-b 7/15/11 acute kidney inj 1226625

7/15/11 death(FU1) 1250501 7/15/11 unresponsiveness 1335267

45

Condensed List of CALGB Audit Updates Revised 2/15/127/15/11 pericard tamp(FU1)13574337/15/11 necrot fasciitis(FU1)16532477/15/11 wound comp(FU1) 17510327/15/11 resp fail(FU1) 17611917/15/11 death 1793638


(Cont)90802 (Cont)


8/15/11 acute kidney inj(FU)1226625 8/15/11 cerebellar synd12582398/15/11 cardiac arrest 12687588/15/11 ascites 14716528/15/11 resp fail(FU) 16456508/15/11 pneumonitis 16751888/15/11 death(FU) 1793638






SAE-b 12/15/11 optic neurop 13015342.er 12/16/11 CF, CAEPR updateSAE-b 1/15/12 pneumothorax 1648456

1/15/12 death 18540331/15/12 LV sys dysf 1988955

3.fb 2/15/12 elig, Rx, Sc Δ, CF,pt letSAE-b 2/15/12 hydrocephalus 1512246

(91 SAEs)

99811 act 5/15/01 clos 6/30/061. 7/15/01 edit2. 6/15/02 Rx, Δ ppt3. 4/15/03 Rx

99904 act 5/15/00 clos 1/12/071. 6/15/00 edit2. 7/15/00 Elig3. 8/15/00 edit4. 1/15/01 edit5. 2/15/01 edit6. 7/15/01 Elig7. 9/15/01 edit8. 3/15/02 edit9. 4/15/02 Elig10. 7/15/02 edit11. 8/15/02 edit12. 12/15/02 edit13. 6/15/03 edit14. 10/15/03 Sc∆15. 6/15/04 edit16. er 4/15/06 Elig, CF17. er 5/15/06 edit18. er 3/15/07 edit

100001 act 11/15/01 clos 3/10/081. 6/15/02 Elig2. 1/15/03 Rx, CF

3. 2/15/03 edit4. 2/15/04 edit5. er 9/15/07 CF

100002 act 12/15/02 clos 3/31/061. 1/15/03 Rx2. 3/15/03 edit

100101 act 12/15/03 clos 3/15/081. 1/15/04 other2. 11/15/04 ∆ ppts3. 2/15/05 EligSAEs 6/30/06(6/30/06) pure red cell aplasia

6/30/06(6/30/06) acute pericarditisSAE-p 2/15/07(2/15/07) resp fail, pneumonia, pul

alveolar hem, RSV infectSuspension 5/4/074.er 8/15/11 CTCAE vers 4.0(3 SAEs)

100102 act 5/15/06 clos 1/31/07SAE 9/15/06(9/15/06) myelitisSAE 10/15/06(10/15/06) ↑ Crt, renal fail, dehyd, infectSAEs 1/15/07(1/15/07) hemorrhagic cystitis

1/15/07(1/15/07) amoebic meningoencephalitis(4 SAEs)

100103 act 1/15/04 clos 12/29/111. fb 4/15/06 elig, Rx, Sc Δ, CF2. er 6/30/06 edit3. fb 6/15/07 Rx, Elig, CF4. er 9/15/07 CF5.er 9/15/08 otherTemp susp 12/29/086.fb 11/2/09 Sc∆, CFReactivation 11/2/097.er 4/15/10 elig8.er 8/15/10 CTCAE version9.fb 12/1/10 CF10.er 12/15/10 edit11.er 11/15/11 RxClosure 12/29/11

100104 act 12/15/04 clos 7/3/09SAE 4/15/05(4/15/05) retinal hemSAEs 7/15/05(7/15/05) thrombotic events

7/15/05(7/15/05) card ischemia/infarct,card troponin, dizziness, pain: card/heart

SAEs 10/15/05(10/15/05) syncope10/15/05(10/15/05) vasculitis10/15/05(10/15/05) lip, perioral infect

SAE 11/15/05(11/15/05) sudden deathAct Ltr 11/22/05 ↑ venous thrombosis & PE SAE 12/15/05(12/15/05) motor neuropathy, ↓ Na1. 1/15/06 ∆ ppts, CF2. 2/15/06 Rx, Elig, CFSAEs 3/15/06(3/15/06) card ischemia/infarct, card

troponin, dizziness, pain: card/heart, autoimmune, antiphospholipid synod

SAE 3/15/06(3/15/06) ↓ pltsSAEs 4/15/06(4/15/06) erythema multiforme

4/15/06(4/15/06) hypoxia,R-sided CHFActLtr 4/5/06(3/29/06) fetal developmentSAE 5/15/06(5/15/06) infect encephalitis, seizure3. 5/15/06 Rx, Elig, CF4. fb 6/30/06 Elig, CF

46

Condensed List of CALGB Audit Updates Revised 2/15/12SAE 7/15/06(7/15/06) dyspnea, pl eff, LE edemaSAEs 8/15/06(8/15/06) ↑ Crt

8/15/06(8/15/06) pul infilt, hypoxiaSAE 9/15/06(9/15/06) motor neurop, somnolence,

speech impairment5. fb 5/15/07 Rx, CF6.nr 6/15/07 edit

(Cont)100104(Cont)

SAE-l 6/15/07 leukoencephalopathySAEs-l 7/15/07 tumor lysis synd

7/15/07 peripheal arterial ischemia w/ soft tiss necrosis of LE

SAE-l 8/15/07 tumor flareSAE-1 9/15/07 central retinal vein occlusSAE-1 10/15/07 infection w/↓ ANC,

pneumonia, deathSAEs-1 11/15/07 ↑ serum HCG, pos urine HCG

11/15/07 resp failSAE-1 12/15/07 tumor lysis synod/flare reactSAE-l 2/15/08 tumor lysis synod/flare reactSAE-l 5/15/08 clonal evolution &

prog from MDS →RAEB-17. fb 6/15/08 Rx, CF, Elig, Sc ΔSAEs-l 7/15/08 pseudotumor cerebri

7/15/08 meningoencephalitisSAE-l 8/15/08 psoriasisSAE-l 9/15/08 GISTSAE-b/l 9/15/08 sudden deathSAE-l 10/15/08 2nd malig, GIST-FUSAE-l 11/15/08 sudden deathSAE-l 12/15/08 sudden death-FUSAE-b/l 2/15/09 sudden death (FU)SAE-b/l 3/15/09 SOB, deathSAE-b/l 4/15/09 deathSAE-l 4/15/09 prog multifocal

leukoencephalopathySAE-b/l 5/15/09 pneumonitis/pul infilt,

atrial fibClosure 7/3/09SAE-b/l 7/15/09 death (FU)SAE-l 8/15/09 lymphoblastic leuk8.er 8/15/09 Sc∆, EligSAEs-l 9/15/09 ↑ Crt phos 1498428SAEs-l 9/15/09 laryn edema 1871314

SAE-l 11/2/09 laryn edema(FU)1871314SAE-l 12/15/09 pneumonitis/pul infilt13967949.er 1/15/10 CFSAE-l 1/15/10 ↑ Crt phos (FU)149842810.er 2/15/10 RxSAE-l 3/15/10 pneumonitis/pul infilt

1396794 (FU)11.er(RRA)3/16/10 CF, CAEPR updateSAE-b/l 4/15/10 pneumonitis 1277486SAE-l 5/15/10 lymph leuk 1203233(FU)SAE-l/b 8/15/10 ONJ 1164386SAE-b/l 10/15/10 ONJ 1963940SAEs-l 10/15/10 meningitis 1528263

10/15/10 hemolysis 1740343SAE-b/l 12/1/10 sudden death 1628411SAE-b/l 1/15/11 ONJ (FU) 1164386SAE-l 1/15/11 hemolysis(FU)1740343 SAE-l 3/15/11 hemolysis 1130645


SAEs-l 4/15/11 ↑ creatinine 13561034/15/11 ↑ creatinine 13846824/15/11 meningitis(FU)1528263

4/15/11 viscer art ischemia 18018244/15/11 ↑ creatinine 1993413

SAE-b/l 5/15/11 ONJ 1963940SAEs-l 5/15/11 hemolysis 1094914

5/15/11 hemolysis(FU)11306455/15/11 cogn disturb(FU)11684335/15/11 neoplasm(FU) 1384682

(Cont)100104(Cont)

SAE-l 5/15/11 ischemic colitis(FU)151865912.er 6/15/11 CF, Act Ltr13.er 7/15/11 CFSAE-l 7/15/11 cardiac arrest 1932440SAE-l/b 8/15/11 choroidal eff 1800822SAE-l 8/15/11 AML 1921183SAE-l/b 9/15/11 multi-organ fail 150693014.fb 9/30/11 CF, CAEPR updateSAEs-l/b 10/15/11 multi-organ fail(FU)1506930

10/15/11 choroidal eff(FU)180082214. correct 11/15/1115.nr 11/15/11 editSAE-l 12/15/11 toxic optic neurop Rpt #lenal-11 SAE-l 2/15/12 2nd ca Rpt #lenal-12(83 SAEs)

100601 act 5/15/101.fb 12/15/10 Sc Δ, CF2.fb 7/15/11 CF, Sc Δ,Elig, Rx

100701 act 2/15/101.er 6/17/10 CF, CAEPR update2.er 8/15/10 CF3.fb 4/15/11 CF4.er 7/15/11 edit5.er 1/15/12 Elig, Rx

100801 act 7/15/101.er 8/15/10 editSAE-a 9/15/10 arterial thrombosis 1071465SAE-a/M 9/15/10 visceral art ischemia 1858271SAE-a/v 9/15/10 pneumonia 19001722.fb 12/15/10 CFSAE-a 2/15/11 perf appendicitis

Rpt # azazcitidine-43.fb 7/15/11 CF, RxSAE-a 8/15/11 rhabdomyolysis

Rpt #azacitidine-54.er 11/15/11 Rx(5 SAEs)

109901 act 3/15/01 clos 4/28/061. 3/15/01 Rx,CF2. 6/15/01 CF3. 7/15/01 CF4. 9/15/01 edit5. 11/15/01 Rx6. 11/15/02 Rx, Elig7. 1/15/03 Rx, CF8. 9/15/04 CF

119901 act 8/15/02 clos 12/15/061. 8/15/03 CF, ∆ ppt2. 8/15/05 ∆ ppt

140202 act 7/15/041. 11/15/04 Elig, CF2. 8/15/05 ∆ ppt3. 7/15/06 Elig, CF

47

Condensed List of CALGB Audit Updates Revised 2/15/124. 1/15/07 edit5.nr 7/15/07 ∆ ppt6.er 10/15/10 edit7.er 5/15/11 CF

140203 act 9/15/04 clos 1/31/071. 11/15/05 edit2. 5/15/06 edit

140302 act 4/15/04 clos 8/15/081. 4/15/05 EligTemp Suspension 8/15/05Reactivation 4/6/062. 10/15/06 edit3.er 1/15/11 edit

140503 act 6/15/071. 6/15/07 edit2. fb 4/15/08 Elig3.er 8/15/09 Elig4.er 3/15/10 CF, Elig5.er 9/15/11 CTCAE version 4.0

140602 act 7/15/07 clos 5/13/111.er 6/15/08 ∆ ppt2.er 5/15/10 elig, Rx∆ to CTSU as PR.11 on 5/6/103.er 7/22/10 edit

150007 act 4/15/02 clos 12/31/101. 7/15/02 edit2. 10/15/02 edit3. 3/15/03 Elig4. 3/15/03 edit5. 5/15/03 Elig6. 7/15/03 CF7. 2/15/04 Sc Δ8. 4/15/04 EligTemp Susp 3/10/06Reactivation 7/15/079. fb 7/15/07 Sc Δ,CF10.fb 7/15/08 Sc Δ,CFPerm Clos 12/31/10

150008 act 12/15/011. 10/15/02 edit

150012 act 5/15/02 clos 12/31/101. 6/15/02 CF2. 11/15/02 edit3. 3/15/03 CFReactivation 7/15/074. fb 7/15/07 Sc Δ,Elig,CF5.fb 8/15/08 Sc Δ,Elig,CF6. fb 12/15/08 Sc Δ,Elig,CF7.er 6/15/10 CFPerm Clos 12/31/10

150201 act 7/15/031. 2/15/07 add correl study

150303 act 2/15/04

150603 act 3/15/10

150601 act 10/13/08

150607 act 9/15/081.er 4/15/10 edit

2.er 4/15/11 edit

150705 act 7/15/071. fb 5/15/08 Sc Δ2.fb 12/15/08 Sc ∆3.fb 10/15/09 Sc ∆4.er 4/15/10 Sc ∆5.er 6/15/10 Sc ∆6.er 11/15/11 ppt , Sc ∆

150713 act 7/15/08

150802 act 7/15/081.er 4/15/11 edit

150803 act 7/15/09

150806 act 9/15/09

150807 act 1/15/12

150809 act 5/15/10

150901 act 7/15/09

150905 act 2/15/10

151003 act 9/15/11

151004 act 12/15/10

151006 act 4/15/11

151102 act 10/15/11

151107 act 10/15/11

15111 act 1/15/12

159905 act 10/15/001. 11/15/01 edit2.fb 7/15/08 Sc Δ,other3.fb 9/15/09 Sc Δ4.fb 10/15/10 Sc Δ

170601 act 4/15/08 clos 3/02/111.er 7/15/08 Sc Δ,CF2.er 9/15/09 Elig, CF3.fb 8/15/10 Elig, CF, Sc ΔMemo 10/15/10 clarif of upate 34.fb 12/1/10 Elig, CFPerm clos 3/2/11

360401 act 12/15/06 clos 7/15/101.er 5/15/07 Elig, CF2.er 2/15/08 editPart clos 6/6/08 Co-hort 65-69Temp clos 1/21/09Perm clos 7/15/10

369901 act 8/1/03 clos 2/15/111. 4/15/04 Elig, CF

48

Condensed List of CALGB Audit Updates Revised 2/15/122. 9/15/04 Elig3. 5/15/05 Elig4. 8/15/05 edit5.nr 8/15/06 edit6. er 2/15/08 CF, Sc , Elig7.er 11/2/09 Sc∆, CFPerm clos 2/15/11

500002 act 8/15/01 clos 1/31/071. 1/15/03 edit2. 2/15/03 Sc , CF3. 5/15/03 CF4. 7/15/03 Elig, Sc ∆5. 11/15/03 other6. 3/15/04 edit7. 5/15/04 edit8. 12/15/04 editSAE 4/15/05(4/15/05) ARDSSAE 6/15/05(6/15/05) confusion/hypoxia/acute

renal fail9. 9/15/05 edit10. 9/15/05 edit11. fb 10/15/07 CF(2 SAEs)

500101 act 2/15/02 clos 10/31/061. 2/15/03 editSAEs 5/15/03(1/15/03) hemiplegia

5/15/03(1/15/03) cholecystitis5/15/03(1/15/03) pericarditis

2. 7/15/03 Sc ∆, CFSAE 9/15/03 pericarditis, hemiplegia(FU)3. 12/15/03 Sc ∆, CF4. 2/15/04 Sc Δ, CFSAE 3/15/05(2/9/05) perianal abscess SAE 7/15/05(6/29/05) atypical chest pain, ↑ WBC 5. 9/15/05 CF, Sc ∆, edit6. 10/15/05 CF, Sc ∆, edit7. 5/15/06 CF8.er 5/15/10 CF(4 SAEs)

500103 act 10/15/02 clos 1/31/071. 3/15/04 edit/add COGSAE 4/15/05(4/15/05) ARDSSAE 6/15/05(6/15/05) confusion/hypoxia/acute

renal fail2. fb 5/15/07 Elig, CF3.er 5/15/07 edit4.er 6/15/07 edit5.er 5/15/08 edit6.fb 10/15/08 Elig, CF7.er 10/15/08 edit8.er 10/15/08 edit9.er 6/15/09 CF10.er 5/15/10 CF(2 SAEs)

500105 act 9/15/02 clos 3/10/061. 10/15/02 edit2. 6/15/03 Elig3. 11/15/03 other4. 2/15/05 edit5. 7/15/05 ↑ ppts

49

8891 · web viewsaes 4/15/05(4/15/05) motor & sensory neuropathy saes 4/15/05(4/15/05) card...

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