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NCT00370331 · ADVERSE EVENTS

Adverse events

RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag · Source last updated 2017-04-18

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
Not reported
Other-event reporting threshold
5%

62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.

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

Matching placebo tablets taken once a day

11 / 6156 / 61Not reported / Not reported
Eltrombopag 50 mg QD

Eltrombopag 50 mg oral tablets taken once a day (QD)

16 / 135120 / 135Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Eltrombopag 50 mg QD

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
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      135
    term
    Cataract
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Cataract subcapsular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Retinal haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      135
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Brain stem haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Loss of consciousness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Alanine aminotransferase (ALT) increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Aspartate aminotransferase (AST) increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Heart rate increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Renal function test abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Transaminases increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Duodenal ulcer haemorrhage

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
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      135
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      135
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      135
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      135
    term
    Influenza
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      135
    term
    Pharyngitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      135
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      135
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      135
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      135
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      135
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      135
    term
    Constipation
Complete source fields
description
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
event Groups
  1. description
    Matching placebo tablets taken once a day
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    61
    serious Num Affected
    11
    serious Num At Risk
    61
    title
    Placebo
  2. description
    Eltrombopag 50 mg oral tablets taken once a day (QD)
    id
    EG001
    other Num Affected
    120
    other Num At Risk
    135
    serious Num Affected
    16
    serious Num At Risk
    135
    title
    Eltrombopag 50 mg QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      135
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      135
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      135
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      135
    term
    Influenza
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      135
    term
    Pharyngitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      135
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      135
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      135
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      135
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      135
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      135
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      135
    term
    Cataract
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Cataract subcapsular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Retinal haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      135
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Brain stem haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Loss of consciousness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Alanine aminotransferase (ALT) increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Aspartate aminotransferase (AST) increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Heart rate increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      135
    term
    Renal function test abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Transaminases increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      135
    term
    Duodenal ulcer haemorrhage

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