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NCT03257631 · ADVERSE EVENTS

Adverse events

A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors · Source last updated 2024-04-16

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
Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).
Other-event reporting threshold
5%

The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Diffuse Intrinsic Pontine Glioma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

9 / 1111 / 1111 / 11
Ependymoma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

4 / 98 / 96 / 9
High-grade Glioma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

14 / 2220 / 2215 / 23
Medulloblastoma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

4 / 109 / 109 / 10

Group identifiers: EG000: Diffuse Intrinsic Pontine Glioma · EG001: Ependymoma · EG002: High-grade Glioma · EG003: Medulloblastoma

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Vision blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Anorectal infection

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Blindness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Conjunctival hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Mydriasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
Complete source fields
description
The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    11
    description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    9
    serious Num At Risk
    11
    title
    Diffuse Intrinsic Pontine Glioma
  2. deaths Num Affected
    6
    deaths Num At Risk
    9
    description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Ependymoma
  3. deaths Num Affected
    15
    deaths Num At Risk
    23
    description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    22
    serious Num Affected
    14
    serious Num At Risk
    22
    title
    High-grade Glioma
  4. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Medulloblastoma
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Blindness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Conjunctival hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Mydriasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Vision blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    term
    Anorectal infection
time Frame
Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).

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Preserved source evidence · Not medical advice