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NCT00516321 · ADVERSE EVENTS

Adverse events

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease · Source last updated 2013-11-05

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
Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72).
Other-event reporting threshold
5%

In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Eltrombopag: OL Phase

Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.

8 / 71549 / 715Not reported / Not reported
Placebo+Antiviral Therapy: DB Phase

Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

35 / 232219 / 232Not reported / Not reported
Eltrombopag+Antiviral Therapy: DB Phase

Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

89 / 449424 / 449Not reported / Not reported

Group identifiers: EG000: Eltrombopag: OL Phase · EG001: Placebo+Antiviral Therapy: DB Phase · EG002: Eltrombopag+Antiviral Therapy: DB Phase

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Gastric Hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Hemorrhoids
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      449
    term
    Large Intestine Perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      449
    term
    Oesophageal Varices Hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      449
    term
    Hepatic Neoplasm Malignant
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      449
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Hypertensive Crisis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Upper Gastrointestinal Hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      449
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      449
    term
    Diarrhea

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
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      107
      num At Risk
      449
    term
    Headache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      170
      num At Risk
      449
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      183
      num At Risk
      449
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      449
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      449
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      449
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      449
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      449
    term
    Influenza Like Illness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      449
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      449
    term
    Edema Peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      449
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      449
    term
    Irritability
Complete source fields
description
In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.
event Groups
  1. description
    Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    715
    serious Num Affected
    8
    serious Num At Risk
    715
    title
    Eltrombopag: OL Phase
  2. description
    Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    EG001
    other Num Affected
    219
    other Num At Risk
    232
    serious Num Affected
    35
    serious Num At Risk
    232
    title
    Placebo+Antiviral Therapy: DB Phase
  3. description
    Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    EG002
    other Num Affected
    424
    other Num At Risk
    449
    serious Num Affected
    89
    serious Num At Risk
    449
    title
    Eltrombopag+Antiviral Therapy: DB Phase
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      107
      num At Risk
      449
    term
    Headache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      170
      num At Risk
      449
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      183
      num At Risk
      449
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      449
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      449
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      449
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      449
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      449
    term
    Influenza Like Illness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      449
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      449
    term
    Edema Peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      449
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      449
    term
    Irritability
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Gastric Hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Hemorrhoids
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      449
    term
    Large Intestine Perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      449
    term
    Oesophageal Varices Hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      449
    term
    Hepatic Neoplasm Malignant
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      449
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      449
    term
    Hypertensive Crisis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      449
    term
    Upper Gastrointestinal Hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      449
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      715
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      449
    term
    Diarrhea
time Frame
Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72).

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Preserved source evidence · Not medical advice