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NCT00636168 · ADVERSE EVENTS

Adverse events

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma · Source last updated 2019-12-17

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
Day 1 up to 70 days after last dose. Up to 10 years.
Other-event reporting threshold
5%

Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IPILIMUMAB 10 MG/KG

Not reported

257 / 471441 / 471173 / 471
PLACEBO

Not reported

128 / 474382 / 474223 / 474

Group identifiers: EG000: IPILIMUMAB 10 MG/KG · EG001: PLACEBO

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
    22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      474
    term
    Lymphadenopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Lymphoid tissue hyperplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Bifascicular block
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiopulmonary failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Coronary artery disease

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      474
    term
    Hypophysitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      474
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      474
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      474
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      474
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      229
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      474
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      474
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      474
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      474
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      188
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      143
      num At Risk
      474
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      474
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      474
    term
    Oedema peripheral
Complete source fields
description
Adverse Events were collected for the safety population which included all 945 randomized subjects who received at least 1 dose of study therapy (471 in the ipilimumab group and 474 in the placebo group)
event Groups
  1. deaths Num Affected
    173
    deaths Num At Risk
    471
    id
    EG000
    other Num Affected
    441
    other Num At Risk
    471
    serious Num Affected
    257
    serious Num At Risk
    471
    title
    IPILIMUMAB 10 MG/KG
  2. deaths Num Affected
    223
    deaths Num At Risk
    474
    id
    EG001
    other Num Affected
    382
    other Num At Risk
    474
    serious Num Affected
    128
    serious Num At Risk
    474
    title
    PLACEBO
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      474
    term
    Hypophysitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      474
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      474
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      474
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      474
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      229
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      474
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      474
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      474
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      474
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      188
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      143
      num At Risk
      474
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      474
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      474
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      474
    term
    Lymphadenopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Lymphoid tissue hyperplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Atrial tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Bifascicular block
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Cardiopulmonary failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      471
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Coronary artery disease
time Frame
Day 1 up to 70 days after last dose. Up to 10 years.

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