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NCT02277444 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy · Source last updated 2025-11-14

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
Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
Other-event reporting threshold
5%

All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w

Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase.

9 / 12774 / 1271 / 127
LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w

Participants who completed Week 52 and entered into the LTE phase, continued to receive 80 mg/m\^2 intravenous golimumab every 8 weeks through Week 244. Those who chose not to enter LTE completed an additional 8-week safety follow-up visit after their final administration of the study agent. All participants who completed Week 244 were monitored for safety through Week 252.

18 / 12757 / 1271 / 127
ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w

Participants who met the inclusion criteria entered the ETP and continued receiving 80 mg/m\^2 intravenous golimumab every 8 weeks from Week 252 to Week 420.

3 / 328 / 320 / 32

Group identifiers: EG000: Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w · EG001: LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w · EG002: ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w

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
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Myopericarditis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Supraventricular Tachycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Glaucoma
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Retinal Detachment
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Crohn's Disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Gastritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Calcinosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Drug Intolerance
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Ocular Implant Exposure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Temperature Regulation Disorder
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Hypersensitivity

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Gastroenteritis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Nasopharyngitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pharyngitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Upper Respiratory Tract Infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Urinary Tract Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Alanine Aminotransferase Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
    term
    Arthritis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Juvenile Idiopathic Arthritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Headache
Complete source fields
description
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    127
    description
    Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase.
    id
    EG000
    other Num Affected
    74
    other Num At Risk
    127
    serious Num Affected
    9
    serious Num At Risk
    127
    title
    Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w
  2. deaths Num Affected
    1
    deaths Num At Risk
    127
    description
    Participants who completed Week 52 and entered into the LTE phase, continued to receive 80 mg/m\^2 intravenous golimumab every 8 weeks through Week 244. Those who chose not to enter LTE completed an additional 8-week safety follow-up visit after their final administration of the study agent. All participants who completed Week 244 were monitored for safety through Week 252.
    id
    EG001
    other Num Affected
    57
    other Num At Risk
    127
    serious Num Affected
    18
    serious Num At Risk
    127
    title
    LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w
  3. deaths Num Affected
    0
    deaths Num At Risk
    32
    description
    Participants who met the inclusion criteria entered the ETP and continued receiving 80 mg/m\^2 intravenous golimumab every 8 weeks from Week 252 to Week 420.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    32
    serious Num Affected
    3
    serious Num At Risk
    32
    title
    ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Gastroenteritis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Nasopharyngitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pharyngitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Upper Respiratory Tract Infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Urinary Tract Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Alanine Aminotransferase Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
    term
    Arthritis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Juvenile Idiopathic Arthritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Myopericarditis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Supraventricular Tachycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Glaucoma
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Retinal Detachment
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Crohn's Disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Gastritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Calcinosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Drug Intolerance
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Ocular Implant Exposure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Temperature Regulation Disorder
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Hypersensitivity
time Frame
Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420

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Preserved source evidence · Not medical advice