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NCT02610140 · ADVERSE EVENTS

Adverse events

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-11-04

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 approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).
Other-event reporting threshold
0%

An "updated" analysis of safety: Treatment-emergent adverse events (TEAEs): defined as all AEs starting or worsening within the treatment period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Anetumab Ravtansine (BAY94-9343)

Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour

56 / 163161 / 163126 / 163
Vinorelbine

Active comparator: 30 mg/m\^2 once weekly

25 / 7268 / 7255 / 72

Group identifiers: EG000: Anetumab Ravtansine (BAY94-9343) · EG001: Vinorelbine

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      163
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ileus paralytic
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Pancreatitis acute

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      163
      num Events
      25
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      72
      num Events
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      12
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      72
      num Events
      80
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      163
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Thrombocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Bundle branch block left
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Coronary artery occlusion
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Palpitations
Complete source fields
description
An "updated" analysis of safety: Treatment-emergent adverse events (TEAEs): defined as all AEs starting or worsening within the treatment period.
event Groups
  1. deaths Num Affected
    126
    deaths Num At Risk
    163
    description
    Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
    id
    EG000
    other Num Affected
    161
    other Num At Risk
    163
    serious Num Affected
    56
    serious Num At Risk
    163
    title
    Anetumab Ravtansine (BAY94-9343)
  2. deaths Num Affected
    55
    deaths Num At Risk
    72
    description
    Active comparator: 30 mg/m\^2 once weekly
    id
    EG001
    other Num Affected
    68
    other Num At Risk
    72
    serious Num Affected
    25
    serious Num At Risk
    72
    title
    Vinorelbine
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      163
      num Events
      25
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      72
      num Events
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      12
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      72
      num Events
      80
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      163
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Thrombocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Bundle branch block left
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Coronary artery occlusion
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Palpitations
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      163
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ileus paralytic
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Pancreatitis acute
time Frame
Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).

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