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NCT00487539 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2014-02-17

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
6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study.
Other-event reporting threshold
2%

The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.

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

Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.

20 / 33061 / 330Not reported / Not reported
Golimumab 100 mg -> 50 mg

Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.

3 / 7118 / 71Not reported / Not reported
Golimumab 200 mg -> 100 mg

Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.

10 / 33154 / 331Not reported / Not reported
Golimumab 400 mg -> 200 mg

Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.

15 / 33255 / 332Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Golimumab 100 mg -> 50 mg · EG002: Golimumab 200 mg -> 100 mg · EG003: Golimumab 400 mg -> 200 mg

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 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Abdominal Pain Upper
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      332
    term
    Colitis Ulcerative
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Adverse Drug Reaction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Anal Abscess
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Brain Abscess
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Bronchitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Candidiasis

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 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      332
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      332
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      332
    term
    Colitis Ulcerative
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      332
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      332
    term
    Injection Site Erythema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      332
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      332
    term
    Nasopharyngitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Oral Herpes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      332
    term
    Arthralgia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Back Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      332
    term
    Headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Insomnia
Complete source fields
description
The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
event Groups
  1. description
    Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    330
    serious Num Affected
    20
    serious Num At Risk
    330
    title
    Placebo
  2. description
    Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    71
    serious Num Affected
    3
    serious Num At Risk
    71
    title
    Golimumab 100 mg -> 50 mg
  3. description
    Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
    id
    EG002
    other Num Affected
    54
    other Num At Risk
    331
    serious Num Affected
    10
    serious Num At Risk
    331
    title
    Golimumab 200 mg -> 100 mg
  4. description
    Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
    id
    EG003
    other Num Affected
    55
    other Num At Risk
    332
    serious Num Affected
    15
    serious Num At Risk
    332
    title
    Golimumab 400 mg -> 200 mg
frequency Threshold
2
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      332
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      332
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      332
    term
    Colitis Ulcerative
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      332
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      332
    term
    Injection Site Erythema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      332
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      332
    term
    Nasopharyngitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Oral Herpes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      332
    term
    Arthralgia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Back Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      332
    term
    Headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Insomnia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Abdominal Pain Upper
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      332
    term
    Colitis Ulcerative
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Adverse Drug Reaction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Anal Abscess
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Brain Abscess
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      332
    term
    Bronchitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      330
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      331
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      332
    term
    Candidiasis
time Frame
6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice