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NCT01456039 · ADVERSE EVENTS

Adverse events

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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
Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum time exposed to study was 1290 days; maximum time on study treatment was 184.3 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

1 / 33 / 3Not reported / Not reported
Phase 1: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

4 / 77 / 7Not reported / Not reported
Phase 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

10 / 4040 / 40Not reported / Not reported
Total: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

14 / 4747 / 47Not reported / Not reported

Group identifiers: EG000: Phase 1: Romidepsin 9mg/m^2 · EG001: Phase 1: Romidepsin 14mg/m^2 · EG002: Phase 2: Romidepsin 14mg/m^2 · EG003: Total: Romidepsin 14mg/m^2

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 (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      47
    term
    Cytomegalovirus infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Bacterial infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Hepatitis B
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumocystis jiroveci pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumonia bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      47
    term
    Akathisia

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 (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      47
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      47
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      47
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      47
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      47
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      47
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      47
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      47
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      47
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      47
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      47
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Abdominal pain upper
Complete source fields
event Groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Phase 1: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    EG002
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    10
    serious Num At Risk
    40
    title
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    EG003
    other Num Affected
    47
    other Num At Risk
    47
    serious Num Affected
    14
    serious Num At Risk
    47
    title
    Total: Romidepsin 14mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      47
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      47
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      47
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      47
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      47
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      47
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      47
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      47
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      47
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      47
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      47
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      47
    term
    Cytomegalovirus infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Bacterial infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Hepatitis B
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumocystis jiroveci pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Pneumonia bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      47
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      47
    term
    Akathisia
time Frame
Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum time exposed to study was 1290 days; maximum time on study treatment was 184.3 weeks

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Preserved source evidence · Not medical advice