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NCT02477826 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2025-10-30

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

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1-Arm B: Nivo + Ipi

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.

275 / 391366 / 391316 / 391
Part 1-Arm A: Nivolumab

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.

239 / 391356 / 391333 / 391
Part 1-Arm C: Chemotherapy

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.

213 / 387361 / 387339 / 387
Part 1-Arm D: Nivo + Ipi

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.

128 / 185172 / 185159 / 185
Part 1-Arm G: Nivo + Chemo

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.

112 / 172167 / 172157 / 172
Part 1-Arm F: Chemotherapy

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.

91 / 183165 / 183174 / 183
Part 2 - Arm H: Nivolumab + Chemotherapy

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.

240 / 375357 / 375314 / 375
Part 2 - Arm I: Chemotherapy

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.

180 / 371345 / 371335 / 371
Part 3 -Arm J: Nivolumab + Ipilimumab

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.

78 / 126124 / 12695 / 126
Part 3 - Arm K: Chemotherapy

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.

60 / 123121 / 12394 / 123

Group identifiers: EG000: Part 1-Arm B: Nivo + Ipi · EG001: Part 1-Arm A: Nivolumab · EG002: Part 1-Arm C: Chemotherapy · EG003: Part 1-Arm D: Nivo + Ipi · EG004: Part 1-Arm G: Nivo + Chemo · EG005: Part 1-Arm F: Chemotherapy · EG006: Part 2 - Arm H: Nivolumab + Chemotherapy · EG007: Part 2 - Arm I: Chemotherapy · EG008: Part 3 -Arm J: Nivolumab + Ipilimumab · EG009: Part 3 - Arm K: Chemotherapy

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Bone marrow failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Eosinophilia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Febrile bone marrow aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Haematotoxicity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Heparin-induced thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Iron deficiency anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Lymphadenopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      123
    term
    Myelosuppression

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      159
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      80
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      76
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      174
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      151
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      63
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      93
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      9
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      123
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      25
      num At Risk
      123
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      45
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      37
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      66
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      58
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      16
      num At Risk
      123
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      48
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      31
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      14
      num At Risk
      123
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      20
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      123
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      33
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      27
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      123
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      123
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      30
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      123
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      22
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      8
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      123
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      63
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      53
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      84
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      83
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      20
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      25
      num At Risk
      123
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      33
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      79
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      48
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      26
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      123
    term
    Diarrhoea
Complete source fields
description
Randomized participants
event Groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      159
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      80
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      76
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      174
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      151
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      63
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      93
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      9
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      123
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      25
      num At Risk
      123
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      45
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      37
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      66
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      58
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      16
      num At Risk
      123
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      48
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      31
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      14
      num At Risk
      123
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      20
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      123
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      33
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      27
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      123
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      123
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      30
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      123
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      22
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      8
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      123
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      63
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      53
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      84
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      83
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      20
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      25
      num At Risk
      123
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      33
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      79
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      48
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      26
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      123
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Bone marrow failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Eosinophilia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Febrile bone marrow aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Haematotoxicity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Heparin-induced thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Iron deficiency anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      126
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      123
    term
    Lymphadenopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      391
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      391
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      387
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      172
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      375
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      371
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      126
    10. 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