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NCT02998528 · ADVERSE EVENTS

Adverse events

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-01-06

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
All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg

Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

30 / 111102 / 11146 / 112
Arm B: Platinum Doublet Chemo

Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

58 / 208202 / 208105 / 214
Arm C: Nivo 360 mg + Platinum Doublet Chemo

Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

53 / 176160 / 17666 / 179

Group identifiers: EG000: Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg · EG001: Arm B: Platinum Doublet Chemo · EG002: Arm C: Nivo 360 mg + Platinum Doublet Chemo

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      176
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Sickle cell anaemia with crisis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Arteriosclerosis coronary artery
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Cardiac failure

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      176
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      176
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      176
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      176
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      176
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      176
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      176
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      176
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      176
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      176
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      176
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      176
    term
    Stomatitis
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants (One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm B (chemo) safety analyses). The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    46
    deaths Num At Risk
    112
    description
    Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
    id
    EG000
    other Num Affected
    102
    other Num At Risk
    111
    serious Num Affected
    30
    serious Num At Risk
    111
    title
    Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
  2. deaths Num Affected
    105
    deaths Num At Risk
    214
    description
    Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
    id
    EG001
    other Num Affected
    202
    other Num At Risk
    208
    serious Num Affected
    58
    serious Num At Risk
    208
    title
    Arm B: Platinum Doublet Chemo
  3. deaths Num Affected
    66
    deaths Num At Risk
    179
    description
    Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
    id
    EG002
    other Num Affected
    160
    other Num At Risk
    176
    serious Num Affected
    53
    serious Num At Risk
    176
    title
    Arm C: Nivo 360 mg + Platinum Doublet Chemo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      176
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      176
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      176
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      176
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      176
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      176
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      176
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      176
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      176
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      176
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      176
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      176
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      176
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Sickle cell anaemia with crisis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      176
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Arteriosclerosis coronary artery
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      111
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      176
    term
    Cardiac failure
time Frame
All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).

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