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NCT02186873 · ADVERSE EVENTS

Adverse events

A Study of Golimumab in Participants With Active Ankylosing Spondylitis · Source last updated 2025-10-30

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
Up to 60 weeks
Other-event reporting threshold
5%

Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.

0 / 1033 / 103Not reported / Not reported
Placebo Then Golimumab 2 mg/kg

Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.

1 / 9916 / 99Not reported / Not reported
Golimumab 2 mg/kg

Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.

6 / 10532 / 105Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Placebo Then Golimumab 2 mg/kg · EG002: Golimumab 2 mg/kg

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 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Sinus tachycardia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pancreatitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Non-alcoholic steatohepatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Appendicitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pneumonia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pulmonary tuberculosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      105
    term
    Wrist fracture
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Henoch-Schonlein purpura

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
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      105
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      105
    term
    Upper respiratory tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      105
    term
    Alanine aminotransferase increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      105
    term
    Headache
Complete source fields
description
Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.
event Groups
  1. description
    Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    103
    serious Num Affected
    0
    serious Num At Risk
    103
    title
    Placebo
  2. description
    Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    99
    serious Num Affected
    1
    serious Num At Risk
    99
    title
    Placebo Then Golimumab 2 mg/kg
  3. description
    Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.
    id
    EG002
    other Num Affected
    32
    other Num At Risk
    105
    serious Num Affected
    6
    serious Num At Risk
    105
    title
    Golimumab 2 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      105
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      105
    term
    Upper respiratory tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      105
    term
    Alanine aminotransferase increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      105
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Sinus tachycardia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pancreatitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Non-alcoholic steatohepatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Appendicitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pneumonia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Pulmonary tuberculosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      105
    term
    Wrist fracture
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      103
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      105
    term
    Henoch-Schonlein purpura
time Frame
Up to 60 weeks

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Preserved source evidence · Not medical advice