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NCT04205643 · ADVERSE EVENTS

Adverse events

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) · Source last updated 2023-09-28

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
For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported.
Other-event reporting threshold
5%

Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CT-P13 IV 5 mg/kg

Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.

23 / 54889 / 5480 / 548
CT-P13 SC 120 mg

Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.

15 / 29660 / 2960 / 296
Placebo

Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.

4 / 14037 / 1400 / 140

Group identifiers: EG000: CT-P13 IV 5 mg/kg · EG001: CT-P13 SC 120 mg · EG002: Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Anaemia (Study drug unrelated)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Iron deficiency anaemia (study drug unrelated)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Aortic valve incompetence (study drug unrelated)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Cardiac failure (study drug unrelated)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      140
    term
    Colitis ulcerative (study drug unrelated)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Duodenal ulcer (study drug unrelated)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Duodenal ulcer perforation (study drug unrelated)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Intestinal obstruction (study drug unrelated)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Intestinal strangulation (study drug unrelated)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Large intestine perforation (study drug unrelated)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Pancreatitis acute (study drug related)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      140
    term
    Rectal haemorrhage (study drug unrelated)

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      140
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      140
    term
    Colitis ulcerative
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      140
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      140
    term
    Nasopharyngitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      140
    term
    Headache
Complete source fields
description
Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    548
    description
    Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    548
    serious Num Affected
    23
    serious Num At Risk
    548
    title
    CT-P13 IV 5 mg/kg
  2. deaths Num Affected
    0
    deaths Num At Risk
    296
    description
    Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.
    id
    EG001
    other Num Affected
    60
    other Num At Risk
    296
    serious Num Affected
    15
    serious Num At Risk
    296
    title
    CT-P13 SC 120 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    140
    description
    Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.
    id
    EG002
    other Num Affected
    37
    other Num At Risk
    140
    serious Num Affected
    4
    serious Num At Risk
    140
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      140
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      140
    term
    Colitis ulcerative
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      140
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      140
    term
    Nasopharyngitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      140
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Anaemia (Study drug unrelated)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Iron deficiency anaemia (study drug unrelated)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Aortic valve incompetence (study drug unrelated)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Cardiac failure (study drug unrelated)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      140
    term
    Colitis ulcerative (study drug unrelated)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Duodenal ulcer (study drug unrelated)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Duodenal ulcer perforation (study drug unrelated)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Intestinal obstruction (study drug unrelated)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Intestinal strangulation (study drug unrelated)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Large intestine perforation (study drug unrelated)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      140
    term
    Pancreatitis acute (study drug related)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      548
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      140
    term
    Rectal haemorrhage (study drug unrelated)
time Frame
For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported.

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