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NCT01444417 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Source last updated 2017-02-09

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 until 4 weeks after last dose; 28 weeks.
Other-event reporting threshold
5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

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

Participants received weekly subcutaneous placebo for 24 weeks.

1 / 1919 / 19Not reported / Not reported
Romiplostim

Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.

10 / 4241 / 42Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Romiplostim

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Thrombocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bronchiolitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Urinary Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Animal Bite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Contusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Petit Mal Epilepsy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Haematuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Nephrotic Syndrome

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Increased Tendency To Bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Iron Deficiency Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Ear Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Conjunctival Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Scleral Discolouration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Abdominal Pain Upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Dyspepsia
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. description
    Participants received weekly subcutaneous placebo for 24 weeks.
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    1
    serious Num At Risk
    19
    title
    Placebo
  2. description
    Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    42
    serious Num Affected
    10
    serious Num At Risk
    42
    title
    Romiplostim
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Increased Tendency To Bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Iron Deficiency Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Ear Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Conjunctival Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Scleral Discolouration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Abdominal Pain Upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Thrombocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bronchiolitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Urinary Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Animal Bite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Contusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Petit Mal Epilepsy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Haematuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Nephrotic Syndrome
time Frame
From the first dose of study drug until 4 weeks after last dose; 28 weeks.

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