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NCT00140855 · ADVERSE EVENTS

Adverse events

A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma · Source last updated 2022-10-12

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
up to 13 weeks
Other-event reporting threshold
0%

All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ipilimumab

Three doses of ipilimumab 3 mg/kg, were administered by intravenous infusion at 3 week intervals. A 6-week observation period followed the final dose.

2 / 66 / 60 / 6

Group identifiers: EG000: Ipilimumab

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Vomiting

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
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Proctalgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Hyperbilirubinemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Blood alkaline phosphatase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Alanine aminotransferase
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Platelet count
Complete source fields
description
All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Three doses of ipilimumab 3 mg/kg, were administered by intravenous infusion at 3 week intervals. A 6-week observation period followed the final dose.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Ipilimumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Proctalgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Hyperbilirubinemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Blood alkaline phosphatase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Alanine aminotransferase
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Platelet count
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 7.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Vomiting
time Frame
up to 13 weeks

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Preserved source evidence · Not medical advice