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NCT00738582 · ADVERSE EVENTS

Adverse events

An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma · Source last updated 2022-09-22

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
From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Amatuximab/Pemetrexed/Cisplatin

Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).

38 / 8989 / 894 / 89
Amatuximab

Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).

15 / 5652 / 560 / 56

Group identifiers: EG000: Amatuximab/Pemetrexed/Cisplatin · EG001: Amatuximab

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Ascites
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Ileus paralytic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Hyperbilirubinaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Calculus urinary
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Renal failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Renal impairment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Intervertebral disc protrusion

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal Pain Lower
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal Tenderness
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anal Fissure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anorectal Discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Bowel Movement Irregularity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Gingivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Glossitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Glossodynia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Ileus Paralytic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Inguinal Hernia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Odynophagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Oesophagitis
Complete source fields
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    89
    description
    Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    89
    serious Num Affected
    38
    serious Num At Risk
    89
    title
    Amatuximab/Pemetrexed/Cisplatin
  2. deaths Num Affected
    0
    deaths Num At Risk
    56
    description
    Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    56
    serious Num Affected
    15
    serious Num At Risk
    56
    title
    Amatuximab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal Pain Lower
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Abdominal Tenderness
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anal Fissure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Anorectal Discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Bowel Movement Irregularity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Gingivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Glossitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Glossodynia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Ileus Paralytic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Inguinal Hernia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
    term
    Odynophagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Oesophagitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Ascites
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Ileus paralytic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Hyperbilirubinaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
    term
    Calculus urinary
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Renal failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Renal impairment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
    term
    Intervertebral disc protrusion
time Frame
From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years

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