NCT02477826 · ADVERSE EVENTS
Adverse events
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
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- Other-event reporting threshold
- 5%
Randomized participants
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Part 1-Arm B: Nivo + Ipi | 275 / 391 | 366 / 391 | 316 / 391 |
| Part 1-Arm A: Nivolumab | 239 / 391 | 356 / 391 | 333 / 391 |
| Part 1-Arm C: Chemotherapy | 213 / 387 | 361 / 387 | 339 / 387 |
| Part 1-Arm D: Nivo + Ipi | 128 / 185 | 172 / 185 | 159 / 185 |
| Part 1-Arm G: Nivo + Chemo | 112 / 172 | 167 / 172 | 157 / 172 |
| Part 1-Arm F: Chemotherapy | 91 / 183 | 165 / 183 | 174 / 183 |
| Part 2 - Arm H: Nivolumab + Chemotherapy | 240 / 375 | 357 / 375 | 314 / 375 |
| Part 2 - Arm I: Chemotherapy | 180 / 371 | 345 / 371 | 335 / 371 |
| Part 3 -Arm J: Nivolumab + Ipilimumab | 78 / 126 | 124 / 126 | 95 / 126 |
| Part 3 - Arm K: Chemotherapy | 60 / 123 | 121 / 123 | 94 / 123 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 8
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 14
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 10
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 2
- num At Risk
- 123
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Autoimmune haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Bone marrow failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Eosinophilia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 2
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 2
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Febrile bone marrow aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 16
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 6
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Haematotoxicity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Heparin-induced thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Iron deficiency anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Lymphadenopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 7
- num At Risk
- 123
- term
- Myelosuppression
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 51
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 159
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 25
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 80
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 76
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 174
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 151
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 63
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 93
- num At Risk
- 123
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 4
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 4
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 9
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 4
- num At Risk
- 123
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 9
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 19
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 15
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 5
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 25
- num At Risk
- 123
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 45
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 37
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 66
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 58
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 16
- num At Risk
- 123
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 39
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 17
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 14
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 48
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 31
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 14
- num At Risk
- 123
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 33
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 11
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 6
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 20
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 3
- num At Risk
- 123
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 61
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 22
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 33
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 4
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 27
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 3
- num At Risk
- 123
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 20
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 10
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 1
- num At Risk
- 123
- term
- Lacrimation increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 30
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 15
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 7
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 4
- num At Risk
- 123
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 22
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 13
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 8
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 2
- num At Risk
- 123
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 78
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 70
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 104
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 36
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 63
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 53
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 84
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 83
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 20
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 25
- num At Risk
- 123
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 102
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 88
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 66
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 44
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 38
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 33
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 79
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 48
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 26
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 8
- num At Risk
- 123
- term
- Diarrhoea
Complete source fields
- description
- Randomized participants
- event Groups
- deaths Num Affected
- 316
- deaths Num At Risk
- 391
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 366
- other Num At Risk
- 391
- serious Num Affected
- 275
- serious Num At Risk
- 391
- title
- Part 1-Arm B: Nivo + Ipi
- deaths Num Affected
- 333
- deaths Num At Risk
- 391
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
- id
- EG001
- other Num Affected
- 356
- other Num At Risk
- 391
- serious Num Affected
- 239
- serious Num At Risk
- 391
- title
- Part 1-Arm A: Nivolumab
- deaths Num Affected
- 339
- deaths Num At Risk
- 387
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG002
- other Num Affected
- 361
- other Num At Risk
- 387
- serious Num Affected
- 213
- serious Num At Risk
- 387
- title
- Part 1-Arm C: Chemotherapy
- deaths Num Affected
- 159
- deaths Num At Risk
- 185
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- EG003
- other Num Affected
- 172
- other Num At Risk
- 185
- serious Num Affected
- 128
- serious Num At Risk
- 185
- title
- Part 1-Arm D: Nivo + Ipi
- deaths Num Affected
- 157
- deaths Num At Risk
- 172
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG004
- other Num Affected
- 167
- other Num At Risk
- 172
- serious Num Affected
- 112
- serious Num At Risk
- 172
- title
- Part 1-Arm G: Nivo + Chemo
- deaths Num Affected
- 174
- deaths Num At Risk
- 183
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG005
- other Num Affected
- 165
- other Num At Risk
- 183
- serious Num Affected
- 91
- serious Num At Risk
- 183
- title
- Part 1-Arm F: Chemotherapy
- deaths Num Affected
- 314
- deaths Num At Risk
- 375
- description
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG006
- other Num Affected
- 357
- other Num At Risk
- 375
- serious Num Affected
- 240
- serious Num At Risk
- 375
- title
- Part 2 - Arm H: Nivolumab + Chemotherapy
- deaths Num Affected
- 335
- deaths Num At Risk
- 371
- description
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG007
- other Num Affected
- 345
- other Num At Risk
- 371
- serious Num Affected
- 180
- serious Num At Risk
- 371
- title
- Part 2 - Arm I: Chemotherapy
- deaths Num Affected
- 95
- deaths Num At Risk
- 126
- description
- Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- EG008
- other Num Affected
- 124
- other Num At Risk
- 126
- serious Num Affected
- 78
- serious Num At Risk
- 126
- title
- Part 3 -Arm J: Nivolumab + Ipilimumab
- deaths Num Affected
- 94
- deaths Num At Risk
- 123
- description
- Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- EG009
- other Num Affected
- 121
- other Num At Risk
- 123
- serious Num Affected
- 60
- serious Num At Risk
- 123
- title
- Part 3 - Arm K: Chemotherapy
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 51
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 159
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 25
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 80
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 76
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 174
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 151
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 63
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 93
- num At Risk
- 123
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 4
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 4
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 9
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 4
- num At Risk
- 123
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 9
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 19
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 15
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 5
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 25
- num At Risk
- 123
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 45
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 37
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 66
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 58
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 16
- num At Risk
- 123
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 39
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 17
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 14
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 48
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 31
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 14
- num At Risk
- 123
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 33
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 11
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 6
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 20
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 3
- num At Risk
- 123
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 61
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 22
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 33
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 4
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 27
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 3
- num At Risk
- 123
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 9
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 20
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 10
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 1
- num At Risk
- 123
- term
- Lacrimation increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 30
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 15
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 7
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 4
- num At Risk
- 123
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 22
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 13
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 8
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 2
- num At Risk
- 123
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 78
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 70
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 104
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 36
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 63
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 53
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 84
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 83
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 20
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 25
- num At Risk
- 123
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 102
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 88
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 66
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 44
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 38
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 33
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 79
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 48
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 26
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 8
- num At Risk
- 123
- term
- Diarrhoea
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 10
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 8
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 14
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 10
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 2
- num At Risk
- 123
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Autoimmune haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Bone marrow failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Eosinophilia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 2
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 2
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Febrile bone marrow aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 16
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 6
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Haematotoxicity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Heparin-induced thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Iron deficiency anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 0
- num At Risk
- 123
- term
- Lymphadenopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 391
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 387
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 185
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 172
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 183
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 375
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 371
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 126
- group Id
- EG009
- num Affected
- 7
- num At Risk
- 123
- term
- Myelosuppression
- time Frame
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
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Preserved source evidence · Not medical advice
Triangle