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NCT03899792 · ADVERSE EVENTS

Adverse events

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors · Source last updated 2026-01-06

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
Baseline up to 64 months
Other-event reporting threshold
0%

The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: MTC Group

Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.

8 / 1515 / 150 / 15
Cohort 2: PTC Group

Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.

4 / 1515 / 150 / 15
Cohort 3: Other Cancer Group

Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.

3 / 65 / 64 / 6

Group identifiers: EG000: Cohort 1: MTC Group · EG001: Cohort 2: PTC Group · EG002: Cohort 3: Other Cancer Group

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Ascites
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastrointestinal fistula
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumatosis intestinalis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Drug hypersensitivity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      4
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Gilbert's syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hydrocele
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    External ear inflammation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Middle ear inflammation
Complete source fields
description
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    8
    serious Num At Risk
    15
    title
    Cohort 1: MTC Group
  2. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    4
    serious Num At Risk
    15
    title
    Cohort 2: PTC Group
  3. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Cohort 3: Other Cancer Group
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      4
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Gilbert's syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hydrocele
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    External ear inflammation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Middle ear inflammation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Ascites
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastrointestinal fistula
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumatosis intestinalis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Drug hypersensitivity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia
time Frame
Baseline up to 64 months

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Preserved source evidence · Not medical advice