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NCT01592370 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month Nivo Dara: approximately 4 years
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. 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
Nivolumab Monotherapy (Expansion)

3mg/kg of nivolumab

50 / 105102 / 10553 / 105
Nivolumab + Ipilimumab

3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W

39 / 6562 / 6533 / 65
Nivolumab + Lirilumab

3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W

34 / 7269 / 7242 / 72
Nivolumab + Daratumumab Cohort A1

ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)

3 / 66 / 61 / 6
Nivolumab + Daratumumab_Cohort A2

ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone

5 / 55 / 53 / 7
Nivolumab + Daratumumab_Cohort B1

ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)

15 / 4135 / 4124 / 42
Nivolumab + Daratumumab_Cohort B2

D regimen: Daratumumab alone

9 / 2216 / 2213 / 23

Group identifiers: EG000: Nivolumab Monotherapy (Expansion) · EG001: Nivolumab + Ipilimumab · EG002: Nivolumab + Lirilumab · EG003: Nivolumab + Daratumumab Cohort A1 · EG004: Nivolumab + Daratumumab_Cohort A2 · EG005: Nivolumab + Daratumumab_Cohort B1 · EG006: Nivolumab + Daratumumab_Cohort B2

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
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    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
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Diverticular perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Immune-mediated enterocolitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
    term
    Sudden cardiac death

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
      23
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      22
    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
      12
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      22
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      22
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dry eye
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Uveitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Vision blurred
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. 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
    53
    deaths Num At Risk
    105
    description
    3mg/kg of nivolumab
    id
    EG000
    other Num Affected
    102
    other Num At Risk
    105
    serious Num Affected
    50
    serious Num At Risk
    105
    title
    Nivolumab Monotherapy (Expansion)
  2. deaths Num Affected
    33
    deaths Num At Risk
    65
    description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    EG001
    other Num Affected
    62
    other Num At Risk
    65
    serious Num Affected
    39
    serious Num At Risk
    65
    title
    Nivolumab + Ipilimumab
  3. deaths Num Affected
    42
    deaths Num At Risk
    72
    description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    EG002
    other Num Affected
    69
    other Num At Risk
    72
    serious Num Affected
    34
    serious Num At Risk
    72
    title
    Nivolumab + Lirilumab
  4. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Nivolumab + Daratumumab Cohort A1
  5. deaths Num Affected
    3
    deaths Num At Risk
    7
    description
    ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Nivolumab + Daratumumab_Cohort A2
  6. deaths Num Affected
    24
    deaths Num At Risk
    42
    description
    ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    EG005
    other Num Affected
    35
    other Num At Risk
    41
    serious Num Affected
    15
    serious Num At Risk
    41
    title
    Nivolumab + Daratumumab_Cohort B1
  7. deaths Num Affected
    13
    deaths Num At Risk
    23
    description
    D regimen: Daratumumab alone
    id
    EG006
    other Num Affected
    16
    other Num At Risk
    22
    serious Num Affected
    9
    serious Num At Risk
    22
    title
    Nivolumab + Daratumumab_Cohort B2
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
      23
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      22
    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
      12
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      22
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      22
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dry eye
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Uveitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Vision blurred
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
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    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
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Diverticular perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Immune-mediated enterocolitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      105
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
    term
    Sudden cardiac death
time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month Nivo Dara: approximately 4 years

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Preserved source evidence · Not medical advice