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NCT01520909 · ADVERSE EVENTS

Adverse events

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10

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
On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of investigational product until follow up (up to 61 weeks).
Other-event reporting threshold
0%

SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Eltrombopag

In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.

5 / 6351 / 63Not reported / Not reported
Part 1: Placebo

In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.

4 / 2919 / 29Not reported / Not reported
Part 2: Eltrombopag

In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.

9 / 8768 / 87Not reported / Not reported

Group identifiers: EG000: Part 1: Eltrombopag · EG001: Part 1: Placebo · EG002: Part 2: Eltrombopag

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
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Gingivitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Meningitis aseptic
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Pneumonia fungal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Alanine aminotransferase abnormal
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aspartate aminotransferase abnormal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      87
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Petechiae
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Hypertensive crisis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Dengue fever

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
      11
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Rhinitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      87
    term
    Epistaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      87
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      87
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      87
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Aspartate Aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      87
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      87
    term
    Alanine Aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Decreased appetite
Complete source fields
description
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
event Groups
  1. description
    In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    63
    serious Num Affected
    5
    serious Num At Risk
    63
    title
    Part 1: Eltrombopag
  2. description
    In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    29
    serious Num Affected
    4
    serious Num At Risk
    29
    title
    Part 1: Placebo
  3. description
    In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
    id
    EG002
    other Num Affected
    68
    other Num At Risk
    87
    serious Num Affected
    9
    serious Num At Risk
    87
    title
    Part 2: Eltrombopag
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Rhinitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      87
    term
    Epistaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      87
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      87
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      87
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      87
    term
    Aspartate Aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      87
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      87
    term
    Alanine Aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Decreased appetite
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Gingivitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Meningitis aseptic
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Pneumonia fungal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Alanine aminotransferase abnormal
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aspartate aminotransferase abnormal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      87
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Petechiae
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Hypertensive crisis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Dengue fever
time Frame
On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of investigational product until follow up (up to 61 weeks).

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Preserved source evidence · Not medical advice