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NCT03926143 · ADVERSE EVENTS

Adverse events

A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies · Source last updated 2023-08-04

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
For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Other-event reporting threshold
0%

Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.

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

Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

2 / 99 / 95 / 9

Group identifiers: EG000: Anetumab Ravtansine

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
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Restrictive cardiomyopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Oedema peripheral
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Urosepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Dyspnoea

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      9
      num Events
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      3
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Restrictive cardiomyopathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hyperthyroidism
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Keratitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Vision blurred
Complete source fields
description
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    9
    description
    Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Anetumab Ravtansine
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      9
      num Events
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      3
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Restrictive cardiomyopathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Hyperthyroidism
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Keratitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Vision blurred
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Restrictive cardiomyopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Oedema peripheral
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Urosepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Dyspnoea
time Frame
For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.

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