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NCT00908037 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) · Source last updated 2018-10-12

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 the investigational product until the end of treatment (up to Study Week 31)
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 (Dose-Finding Period)

Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.

2 / 1515 / 15Not reported / Not reported
Part 2 (Randomized Period) -Placebo

Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.

2 / 2120 / 21Not reported / Not reported
Part 2 (Randomized Period) - Eltrombopag

Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.

4 / 4436 / 44Not reported / Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)

Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.

8 / 6562 / 65Not reported / Not reported

Group identifiers: EG000: Part 1 (Dose-Finding Period) · EG001: Part 2 (Randomized Period) -Placebo · EG002: Part 2 (Randomized Period) - Eltrombopag · EG003: Part 2/ 3 (Eltrombopag Open-Label Period)

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Epistaxis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Impetigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Varicella
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Conjunctivitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Lenticular opacities
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Vitreous opacities
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Alanine aminotransferase increased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      65
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      65
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
    term
    Toothache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Gingival bleeding
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Haematochezia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Breath odour
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Constipation
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
    Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    2
    serious Num At Risk
    15
    title
    Part 1 (Dose-Finding Period)
  2. description
    Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
    id
    EG001
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    2
    serious Num At Risk
    21
    title
    Part 2 (Randomized Period) -Placebo
  3. description
    Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
    id
    EG002
    other Num Affected
    36
    other Num At Risk
    44
    serious Num Affected
    4
    serious Num At Risk
    44
    title
    Part 2 (Randomized Period) - Eltrombopag
  4. description
    Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
    id
    EG003
    other Num Affected
    62
    other Num At Risk
    65
    serious Num Affected
    8
    serious Num At Risk
    65
    title
    Part 2/ 3 (Eltrombopag Open-Label Period)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      65
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      65
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
    term
    Toothache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Gingival bleeding
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Haematochezia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Breath odour
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Epistaxis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Impetigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Varicella
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Conjunctivitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Lenticular opacities
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Vitreous opacities
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
    term
    Alanine aminotransferase increased
time Frame
On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)

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Preserved source evidence · Not medical advice