B. PANITUMUMAB DOSE LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle
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1 Radiation Therapy Oncology Group Phase II Study Pre-operative Chemo- Radiation + Panitumumab for Potentially Operable Lung Cancer Concurrent Summary Form AMENDED DATA YES INSTRUCTIONS: Submit all pages of this form according to time points in section 12.0 of the protocol. Record dates MM/DD/YYYY 1. ASSIGNED TREATMENT ARM(1) 2.. HEIGHT (CM)(2) 1 Arm 1 2 Arm 2 A. WAS DRUG MODIFIED/DELAYED? modification/delay 2 Reduced dose, planned (per protocol) 3 Reduced dose, not planned (not per protocol) 4 Exceeded protocol dose 5 Delayed B. PANITUMUMAB LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle C. PACLITAXEL LEVEL 0 No dose reduction 98 Other, specify in comments for this cycle D. CARBOPLATIN LEVEL 0 No dose reduction 98 Other, specify in comments for this cycle E. REASON FOR MODIFICATION modification 2 Disease progression, relapse during active treatment 3 Adverse event / side effect / complication* 4 Death on study 5 Patient withdrawal / refusal after beginning protocol therapy 6 Patient withdrawal / refusal prior to beginning protocol therapy 7 Alternative therapy, specify in comments 8 Other complicating disease, specify in comments 98 Other, specify in comments *Must code specific MedDRA Code in Q 9 Specify reason in cycle comments F. REASON TREATMENT TERMINATED 0 Not applicable, treatment not terminated 1 Treatment completed per protocol criteria 2 Disease progression, relapse during active treatment 3 Adverse event / side effect / complication* 4 Death on study 5 Patient withdrawal / refusal after beginning protocol therapy 6 Patient withdrawal / refusal prior to beginning protocol therapy 7 Alternative therapy, specify in comments 8 Patient off (protocol) treatment for other complicating disease (followup and data submission will continue) 98 Other, specify in comments *Must code specific MedDRA Code in Q 10 Specify reason in cycle comments 3. WEEK 1. WEIGHT (KG)(3). BSA(M 2 )(4) DATE AGENT START - - (6) - - (13) - - (20) DATE AGENT END - - (7) - - (14) - - (21) AGENT TOTAL (mg)(8) (mg)(15) (mg)(22) CLEARANCE ml/min(5) (USE CODE TABLE A) (9) (16) (23) MODIFIED LEVEL (USE CODE TABLE B-D) (10) (17) (24) (USE CODE TABLE E) (11) (18) (25) (USE CODE TABLE F) (12) (19) (26) COMMENTS (for this cycle) (27-28) 0839 TFa of 8
2 4. WEEK 2. WEIGHT (KG)(29). BSA(M 2 )(30) DATE AGENT START - - (32) - - (39) - - (46) DATE AGENT END - - (33) - - (40) - - (47) AGENT TOTAL (mg)(34) (mg)(41) (mg)(48) CLEARANCE ml/min(31) (USE CODE TABLE A) (35) (42) (49) MODIFIED LEVEL (USE CODE TABLE B-D) (36) (43) (50) (USE CODE TABLE E) (37) (44) (51) (USE CODE TABLE F) (38) (45) (52) COMMENTS (for this cycle) (53-54) 5. WEEK 3. WEIGHT (KG)(55). BSA(M 2 )(56 DATE AGENT START - - (58) - - (65) - - (72) DATE AGENT END - - (59) - - (66) - - (73) AGENT TOTAL (mg)(60) (mg)(67) (mg)(74) CLEARANCE ml/min(57) (USE CODE TABLE A) (61) (68) (75) MODIFIED LEVEL (USE CODE TABLE B-D) (62) (69) (76) (USE CODE TABLE E) (63) (70) (77) (USE CODE TABLE F) (64) (71) (78) COMMENTS (for this cycle) (79-80) 0839 TFa of 8
3 6. WEEK 4. WEIGHT (KG)(81). BSA(M 2 )(82) DATE AGENT START - - (84) - - (91) - - (98) DATE AGENT END - - (85) - - (92) - - (99) AGENT TOTAL (mg)(86) (mg)(93) (mg)(100) CLEARANCE ml/min(83) (USE CODE TABLE A) (87) (94) (101) MODIFIED LEVEL (USE CODE TABLE B-D) (88) (95) (102) (USE CODE TABLE E) (89) (96) (103) (USE CODE TABLE F) (90) (97) (104) COMMENTS (for this cycle) ( ) 7. WEEK 5. WEIGHT (KG)(107). BSA(M 2 )(108) DATE AGENT START - - (110) - - (117) - - (124) DATE AGENT END - - (111) - - (118) - - (125) AGENT TOTAL (mg)(112) (mg)(119) (mg)(126) CLEARANCE ml/min(109) (USE CODE TABLE A) (113) (120) (127) MODIFIED LEVEL (USE CODE TABLE B-D) (114) (121) (128) (USE CODE TABLE E) (115) (122) (129) (USE CODE TABLE F) (116) (123) (130) COMMENTS (for this cycle) ( ) 0839 TFa of 8
4 8. WEEK 6. WEIGHT (KG)(133). BSA(M 2 )(134) DATE AGENT START - - (136) - - (143) - - (150) DATE AGENT END - - (137) - - (144) - - (151) AGENT TOTAL (mg)(138) (mg)(145) (mg)(152) CLEARANCE ml/min(135) (USE CODE TABLE A) (139) (146) (153) MODIFIED LEVEL (USE CODE TABLE B-D) (140) (147) (154) (USE CODE TABLE E) (141) (148) (155) (USE CODE TABLE F) (142) (149) (156) COMMENTS (for this cycle) ( ) 0839 TFa of 8
5 9. SPECIFY AE THAT CAUSED TREATMENT MODIFICATION/DELAY. USE CTC AE VERSION 4.0 MedDRA INDICATE WHICH DRUG(S) WERE MODIFIED/DELAYED USING CODE TABLE I BELOW. I. DRUG MODIFICATION/ DELAY CODE TABLE A. CTC AE ATTRIBUTION CODE ANY PROTOCOL TREATMENT (Including investigational agent) B. SAE REPORT SUBMITTED* 9 Unknown C. ATTRIBUTION CODE FOR THE INVESTIGATIONAL AGENT MODIFICATION USE CODE TABLE I MedDRA AE CODE Week # Start Date(mandatory) Pan. Pacl. Carbo. Grade A B C (848) (849) - - (850) (851) (852) (853) (854) (855) (856) (857) (858) (859) - - (860) (861) (862) (863) (864) (865) (866) (867) (868) (869) - - (870) (871) (872) (873) (874) (875) (876) (877) (878) (879) - - (880) (881) (882) (883) (884) (885) (886) (887) (888) (889) - - (890) (891) (892) (893) (894) (895) (896) (897) (898) (899) - - (900) (901) (902) (903) (904) (905) (906) (907) (908) (909) - - (910) (911) (912) (913) (914) (915) (916) (917) (918) (919) - - (920) (921) (922) (923) (924) (925) (926) (927) (928) (929) - - (930) (931) (932) (933) (934) (935) (936) (937) (938) (939) - - (940) (941) (942) (943) (944) (945) (946) (947) 10. SPECIFY AE THAT CAUSED TREATMENT. USE CTC AE VERSION 4.0 MedDRA INDICATE WHICH DRUG(S) WERE TERMINATED USING CODE TABLE II BELOW. II. DRUG CODE TABLE A. CTC AE ATTRIBUTION CODE ANY PROTOCOL TREATMENT (Including investigational agent) B. SAE REPORT SUBMITTED* 9 Unknown C. ATTRIBUTION CODE FOR THE INVESTIGATIONAL AGENT USE CODE TABLE II MedDRA AE CODE Week # Start Date(mandatory) Pan. Pacl. Carbo. GRADE A B C (1048) (1049) - - (1050) (1051) (1052) (1053) (1054) (1055) (1056) (1057) (1058) (1059) - - (1060) (1061) (1062) (1063) (1064) (1065) (1066) (1067) (1068) (1069) - - (1070) (1071) (1072) (1073) (1074) (1075) (1076) (1077) (1078) (1079) - - (1080) (1081) (1082) (1083) (1084) (1085) (1086) (1087) (1088) (1089) - - (1090) (1091) (1092) (1093) (1094) (1095) (1096) (1097) {*If SAE reported, AE grade, start date, and attributions must match on ADEERS report and CRF} 0839 TFa of 8
6 11. ANY OTHER TREATMENT RELATED ADVERSE EVENTS?(159) 9 Unknown Adverse Events: Use the CTCAE version 4 (MedDRA 12) to code all events. Score most severe grade observed during report period (grade 1-5). Adverse Events of grade 3 or higher require start date. Assign attribution to protocol treatment for each AE and indicate if an SAE was reported. Adverse events reported in Q9 or Q10 should only be reported here if the grade is worse than reported in Q9 and/or Q10. A. Attribution to Protocol Treatment Adverse Event Code B. SAE Report Submitted 9 Unknown CTCAE V4 Term (specify if "other") Grade Start Date A B (301) (302) (303) - - (304) (305) (306) (307) (308) (309) - - (310) (311) (312) (313) (314) (315) - - (316) (317) (318) (319) (320) (321) - - (322) (323) (324) (325) (326) (327) - - (328) (329) (330) (331) (332) (333) - - (334) (335) (336) (337) (338) (339) - - (340) (341) (342) (343) (344) (345) - - (346) (347) (348) (349) (350) (351) - - (352) (353) (354) (355) (356) (357) - - (358) (359) (360) (361) (362) (363) - - (364) (365) (366) (367) (368) (369) - - (370) (371) (372) (373) (374) (375) - - (376) (377) (378) (379) (380) (381) - - (382) (383) (384) (385) (386) (387) - - (388) (389) (390) (391) (392) (393) - - (394) (395) (396) (397) (398) (399) - - (400) (401) (402) (403) (404) (405) - - (406) (407) (408) (409) (410) (411) - - (412) (413) (414) Comments ( ) 0839 TFa of 8
7 UNITS(1098) 1 Conventional (use flowsheet below) 2 SI (skip to Q#17 flowsheet) 12. INSTRUCTIONS: Record laboratory values USING STANDARD U.S. UNITS and normal ranges. See protocol for lab schedules Grade lab abnormalities on page 4 and/or 5. Normal Range Pre-Rx Date (mm/dd) Year: / / / / / / / / Hgb (g/dl) Hct (%) WBC (x1000) mm 3 Platelets (x1000) mm 3 Neutrophils (%) ANC (mm 3 ) Sodium (meq/l) Potassium (meq/l) Chloride (meq/l) BUN (mg/dl) Creatinine (mg/dl) Calc. Creatinine Clear. (ml/min) Total Bilirubin (mg/dl) Alk PO4 (ImU/ml) LDH (U/L) SGOT (IU/L) SGPT (IU/L) Total Protein (g/dl) Albumin (g/dl) Uric Acid (mg/dl) Calcium (mg/dl) Glucose(mg/dl) Mg (meq/l) U/A COMMENTS ( ) The reported case report information has been reviewed and confirmed by the principal investigator. (1101) Investigator Signature - - (1102) Date 0839 TFa of 8
8 13. INSTRUCTIONS: Record laboratory values USING STANDARD INTERNATIONAL UNITS and normal ranges. See protocol for lab schedules Grade lab abnormalities on page 4 and/or 5. Normal Range Pre-Rx Date (mm/dd) Year: / / / / / / / / Hgb (mmol/l) Hct (volume fraction) WBC (x10 9 liter) Platelets (x10 9 liter) Neutrophils (fraction) ANC (mm 3 ) Sodium (mmol/l) Potassium (mmol/l) Chloride (mmol/l) BUN (mmol/l) Creatinine (umol/l) Calc. Creatinine Clear. (ml/sec/m 2 ) Total Bilirubin (umol/l) Alk PO4 (U/L) LDH (IU/L) SGOT (U/L) SGPT (U/L) Total Protein (g/l) Albumin (g/l) Uric Acid (mmol/l) Calcium (mmol/l) Glucose (mmol/l) Mg (mmol/l) U/A COMMENTS ( ) The reported case report information has been reviewed and confirmed by the principal investigator. (1105) Investigator Signature - - (1106) Date 0839 TFa of 8
ASSIGNED TREATMENT ARM
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