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NCT02357147 · ADVERSE EVENTS

Adverse events

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-03-17

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
From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Other-event reporting threshold
5%

Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin

During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

15 / 5250 / 526 / 52
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin

During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

11 / 5451 / 543 / 54
Maintenance Treatment Phase: Amatuximab

Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

1 / 2519 / 252 / 25
Maintenance Treatment Phase: Placebo

Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

4 / 2921 / 291 / 29

Group identifiers: EG000: Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin · EG001: Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin · EG002: Maintenance Treatment Phase: Amatuximab · EG003: Maintenance Treatment Phase: 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
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Amaurosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    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 (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
      num Events
      29
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      54
      num Events
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
      num Events
      35
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      54
      num Events
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      52
      num Events
      27
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      54
      num Events
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
      num Events
      17
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      54
      num Events
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      52
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Dyspepsia
Complete source fields
description
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    52
    description
    During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    52
    serious Num Affected
    15
    serious Num At Risk
    52
    title
    Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
  2. deaths Num Affected
    3
    deaths Num At Risk
    54
    description
    During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    54
    serious Num Affected
    11
    serious Num At Risk
    54
    title
    Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
  3. deaths Num Affected
    2
    deaths Num At Risk
    25
    description
    Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    25
    serious Num Affected
    1
    serious Num At Risk
    25
    title
    Maintenance Treatment Phase: Amatuximab
  4. deaths Num Affected
    1
    deaths Num At Risk
    29
    description
    Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    29
    serious Num Affected
    4
    serious Num At Risk
    29
    title
    Maintenance Treatment Phase: Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
      num Events
      29
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      54
      num Events
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
      num Events
      35
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      54
      num Events
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      52
      num Events
      27
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      54
      num Events
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
      num Events
      17
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      54
      num Events
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      52
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Amaurosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Vomiting
time Frame
From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice