NCT00686959 · ADVERSE EVENTS

Adverse events

Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer · Source last updated 2016-06-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Not reported
Other-event reporting threshold: 5%

Randomized participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles.	134 / 283	279 / 283	Not reported / Not reported
Arm B: Etoposide + Cisplatin and TRT Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase	145 / 272	269 / 272	Not reported / Not reported

Group identifiers: EG000: Arm A: · EG001: Arm B: Etoposide + Cisplatin and TRT

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
3
num At Risk
283
num Events
6
group Id
EG001
num Affected
5
num At Risk
272
num Events
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
12
num At Risk
283
num Events
14
group Id
EG001
num Affected
24
num At Risk
272
num Events
25
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
4
num At Risk
283
num Events
6
group Id
EG001
num Affected
6
num At Risk
272
num Events
12
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
1
num At Risk
272
num Events
11
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
8
num At Risk
283
num Events
21
group Id
EG001
num Affected
13
num At Risk
272
num Events
16
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
2
num At Risk
272
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
4
group Id
EG001
num Affected
5
num At Risk
272
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
4
num At Risk
283
num Events
11
group Id
EG001
num Affected
3
num At Risk
272
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
283
num Events
0
group Id
EG001
num Affected
2
num At Risk
272
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
0
num At Risk
272
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
0
num At Risk
272
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
283
num Events
0
group Id
EG001
num Affected
1
num At Risk
272
num Events
1
term
Coronary artery disease

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
88
num At Risk
283
num Events
336
group Id
EG001
num Affected
94
num At Risk
272
num Events
312
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
63
num At Risk
283
num Events
267
group Id
EG001
num Affected
71
num At Risk
272
num Events
237
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
62
num At Risk
283
num Events
297
group Id
EG001
num Affected
47
num At Risk
272
num Events
170
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
92
num At Risk
283
num Events
252
group Id
EG001
num Affected
123
num At Risk
272
num Events
359
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
39
num At Risk
283
num Events
116
group Id
EG001
num Affected
53
num At Risk
272
num Events
132
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
15
num At Risk
283
num Events
40
group Id
EG001
num Affected
8
num At Risk
272
num Events
27
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
35
num At Risk
283
num Events
94
group Id
EG001
num Affected
8
num At Risk
272
num Events
13
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
112
num At Risk
283
num Events
312
group Id
EG001
num Affected
129
num At Risk
272
num Events
284
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
55
num At Risk
283
num Events
88
group Id
EG001
num Affected
63
num At Risk
272
num Events
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
43
num At Risk
283
num Events
148
group Id
EG001
num Affected
37
num At Risk
272
num Events
95
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
140
num At Risk
283
num Events
567
group Id
EG001
num Affected
110
num At Risk
272
num Events
317
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
175
num At Risk
283
num Events
532
group Id
EG001
num Affected
144
num At Risk
272
num Events
365
term
Nausea

Complete source fields

description

Randomized participants who received at least one dose of study drug.

event Groups

description
Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles.
id
EG000
other Num Affected
279
other Num At Risk
283
serious Num Affected
134
serious Num At Risk
283
title
Arm A:
description
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase
id
EG001
other Num Affected
269
other Num At Risk
272
serious Num Affected
145
serious Num At Risk
272
title
Arm B: Etoposide + Cisplatin and TRT

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
88
num At Risk
283
num Events
336
group Id
EG001
num Affected
94
num At Risk
272
num Events
312
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
63
num At Risk
283
num Events
267
group Id
EG001
num Affected
71
num At Risk
272
num Events
237
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
62
num At Risk
283
num Events
297
group Id
EG001
num Affected
47
num At Risk
272
num Events
170
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
92
num At Risk
283
num Events
252
group Id
EG001
num Affected
123
num At Risk
272
num Events
359
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
39
num At Risk
283
num Events
116
group Id
EG001
num Affected
53
num At Risk
272
num Events
132
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
15
num At Risk
283
num Events
40
group Id
EG001
num Affected
8
num At Risk
272
num Events
27
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
35
num At Risk
283
num Events
94
group Id
EG001
num Affected
8
num At Risk
272
num Events
13
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
112
num At Risk
283
num Events
312
group Id
EG001
num Affected
129
num At Risk
272
num Events
284
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
55
num At Risk
283
num Events
88
group Id
EG001
num Affected
63
num At Risk
272
num Events
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
43
num At Risk
283
num Events
148
group Id
EG001
num Affected
37
num At Risk
272
num Events
95
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
140
num At Risk
283
num Events
567
group Id
EG001
num Affected
110
num At Risk
272
num Events
317
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
175
num At Risk
283
num Events
532
group Id
EG001
num Affected
144
num At Risk
272
num Events
365
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
3
num At Risk
283
num Events
6
group Id
EG001
num Affected
5
num At Risk
272
num Events
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
12
num At Risk
283
num Events
14
group Id
EG001
num Affected
24
num At Risk
272
num Events
25
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
4
num At Risk
283
num Events
6
group Id
EG001
num Affected
6
num At Risk
272
num Events
12
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
1
num At Risk
272
num Events
11
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
8
num At Risk
283
num Events
21
group Id
EG001
num Affected
13
num At Risk
272
num Events
16
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
2
num At Risk
272
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
4
group Id
EG001
num Affected
5
num At Risk
272
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
4
num At Risk
283
num Events
11
group Id
EG001
num Affected
3
num At Risk
272
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
283
num Events
0
group Id
EG001
num Affected
2
num At Risk
272
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
0
num At Risk
272
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
283
num Events
1
group Id
EG001
num Affected
0
num At Risk
272
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
283
num Events
0
group Id
EG001
num Affected
1
num At Risk
272
num Events
1
term
Coronary artery disease

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