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NCT00529568 · ADVERSE EVENTS

Adverse events

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C 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 52).
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 \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 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 \>=100 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 \>=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.

9 / 8050 / 805Not 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-2b 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).

49 / 252226 / 252Not 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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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).

119 / 506459 / 506Not 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
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Arthritis bacterial
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      506
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      506
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Gastric varices hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      506
    term
    Hepatorenal syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Spinal compression fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Blood creatinine increased
  8. 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
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      506
    term
    Hepatic neoplasm malignant
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      506
    term
    Suicidal ideation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      506
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      506
    term
    Gastrointestinal hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      506
    term
    Esophageal varices hemorrhage

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
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      141
      num At Risk
      506
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      124
      num At Risk
      506
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      100
      num At Risk
      506
    term
    Influenza like illness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      506
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      506
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      506
    term
    Irritability
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      506
    term
    Edema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      506
    term
    Injection site erythema
  9. 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
      805
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      200
      num At Risk
      506
    term
    Anemia
  10. 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
      805
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      506
    term
    Neutropenia
  11. 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
      805
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      506
    term
    Thrombocytopenia
  12. 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
      805
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      506
    term
    Leukopenia
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 \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 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 \>=100 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 \>=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    805
    serious Num Affected
    9
    serious Num At Risk
    805
    title
    Eltrombopag: OL Phase
  2. description
    Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b 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
    226
    other Num At Risk
    252
    serious Num Affected
    49
    serious Num At Risk
    252
    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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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
    459
    other Num At Risk
    506
    serious Num Affected
    119
    serious Num At Risk
    506
    title
    Eltrombopag+Antiviral Therapy: DB Phase
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      141
      num At Risk
      506
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      124
      num At Risk
      506
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      100
      num At Risk
      506
    term
    Influenza like illness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      506
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      506
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      506
    term
    Irritability
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      506
    term
    Edema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      506
    term
    Injection site erythema
  9. 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
      805
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      200
      num At Risk
      506
    term
    Anemia
  10. 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
      805
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      506
    term
    Neutropenia
  11. 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
      805
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      506
    term
    Thrombocytopenia
  12. 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
      805
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      506
    term
    Leukopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Arthritis bacterial
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      506
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      506
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Gastric varices hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      506
    term
    Hepatorenal syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Spinal compression fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      506
    term
    Blood creatinine increased
  8. 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
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      506
    term
    Hepatic neoplasm malignant
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      506
    term
    Suicidal ideation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      506
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      506
    term
    Gastrointestinal hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      805
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      252
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      506
    term
    Esophageal varices hemorrhage
time Frame
Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 52).

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Preserved source evidence · Not medical advice