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NCT03945019 · ADVERSE EVENTS

Adverse events

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) · Source last updated 2023-10-23

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.

12 / 39651 / 3960 / 396
CT-P13 SC 120 mg (Including 240 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.

16 / 23875 / 2381 / 238
CT-P13 SC 120 mg

Patients who administered CT-P13 SC 120 mg 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.

15 / 23870 / 2381 / 238
CT-P13 SC 120 mg to 240 mg

Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22.

1 / 459 / 450 / 45
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.

8 / 10530 / 1050 / 105

Group identifiers: EG000: CT-P13 IV 5 mg/kg · EG001: CT-P13 SC 120 mg (Including 240 mg) · EG002: CT-P13 SC 120 mg · EG003: CT-P13 SC 120 mg to 240 mg · EG004: 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
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Anaemia (study drug unrelated)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Cardiovascular insufficiency (study drug unrelated)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Crohn's disease (study drug unrelated)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Haemorrhoids (study drug unrelated)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Intestinal obstruction (study drug unrelated)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Intestinal perforation (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
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Subileus (study drug unrelated)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Accidental death (study drug unrelated)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal abscess (study drug unrelated)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal sepsis (study drug unrelated)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal wall abscess (study drug unrelated)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abscess intestinal (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
      16
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      105
    term
    Crohn's disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    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
    396
    description
    Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    396
    serious Num Affected
    12
    serious Num At Risk
    396
    title
    CT-P13 IV 5 mg/kg
  2. deaths Num Affected
    1
    deaths Num At Risk
    238
    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
    75
    other Num At Risk
    238
    serious Num Affected
    16
    serious Num At Risk
    238
    title
    CT-P13 SC 120 mg (Including 240 mg)
  3. deaths Num Affected
    1
    deaths Num At Risk
    238
    description
    Patients who administered CT-P13 SC 120 mg 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
    70
    other Num At Risk
    238
    serious Num Affected
    15
    serious Num At Risk
    238
    title
    CT-P13 SC 120 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    45
    description
    Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    45
    serious Num Affected
    1
    serious Num At Risk
    45
    title
    CT-P13 SC 120 mg to 240 mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    105
    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
    EG004
    other Num Affected
    30
    other Num At Risk
    105
    serious Num Affected
    8
    serious Num At Risk
    105
    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
      16
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      105
    term
    Crohn's disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      105
    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
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Anaemia (study drug unrelated)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Cardiovascular insufficiency (study drug unrelated)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Crohn's disease (study drug unrelated)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Haemorrhoids (study drug unrelated)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Intestinal obstruction (study drug unrelated)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      105
    term
    Intestinal perforation (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
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Subileus (study drug unrelated)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Accidental death (study drug unrelated)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal abscess (study drug unrelated)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal sepsis (study drug unrelated)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abdominal wall abscess (study drug unrelated)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      238
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      105
    term
    Abscess intestinal (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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Preserved source evidence · Not medical advice