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NCT03596645 · ADVERSE EVENTS

Adverse events

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2026-08-31

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
All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70
Other-event reporting threshold
3%

(Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.

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

In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.

28 / 6962 / 690 / 69
Group 2: Infliximab

In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.

2 / 1413 / 140 / 14

Group identifiers: EG000: Group 1: Golimumab · EG001: Group 2: Infliximab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Colitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Colitis Ulcerative
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Pancreatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Clostridium Difficile Infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Covid-19
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cytomegalovirus Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Cytomegalovirus Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pseudomembranous Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Stump Appendicitis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal Discomfort
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal Distension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      14
    term
    Colitis Ulcerative
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Flatulence
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Haematochezia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Mucous Stools
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Nausea
Complete source fields
description
(Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    69
    description
    In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
    id
    EG000
    other Num Affected
    62
    other Num At Risk
    69
    serious Num Affected
    28
    serious Num At Risk
    69
    title
    Group 1: Golimumab
  2. deaths Num Affected
    0
    deaths Num At Risk
    14
    description
    In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    2
    serious Num At Risk
    14
    title
    Group 2: Infliximab
frequency Threshold
3
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal Discomfort
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal Distension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      14
    term
    Colitis Ulcerative
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Flatulence
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Haematochezia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Mucous Stools
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Nausea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Colitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Colitis Ulcerative
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Pancreatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Clostridium Difficile Infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Covid-19
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cytomegalovirus Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Cytomegalovirus Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pseudomembranous Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Stump Appendicitis
time Frame
All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70

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Preserved source evidence · Not medical advice