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NCT01344876 · ADVERSE EVENTS

Adverse events

Phase I Study of OPB-51602 in Patients With Hematologic Malignancies · Source last updated 2015-06-08

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
From first dose of study medication to 30 days after last dose of study medication.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
OPB-51602 1mg/Day

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

1 / 44 / 4Not reported / Not reported
OPB-51602 2mg/Day

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

0 / 33 / 3Not reported / Not reported
OPB-51602 3mg/Day

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

2 / 44 / 4Not reported / Not reported
OPB-51602 4mg/Day

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

0 / 66 / 6Not reported / Not reported
OPB-51602 6mg/Day

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

0 / 33 / 3Not reported / Not reported

Group identifiers: EG000: OPB-51602 1mg/Day · EG001: OPB-51602 2mg/Day · EG002: OPB-51602 3mg/Day · EG003: OPB-51602 4mg/Day · EG004: OPB-51602 6mg/Day

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 Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Decreased appetite
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Peripheral sensory neuropathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Spinal cord infarction

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 Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      6
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      4
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      5
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      4
    term
    White blood cell count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Blood lactate dehydrogenase increased
Complete source fields
event Groups
  1. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    OPB-51602 1mg/Day
  2. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    OPB-51602 2mg/Day
  3. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    OPB-51602 3mg/Day
  4. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    OPB-51602 4mg/Day
  5. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    OPB-51602 6mg/Day
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      6
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      4
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      5
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      3
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      4
    term
    White blood cell count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Blood lactate dehydrogenase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Decreased appetite
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Peripheral sensory neuropathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Ver.16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Spinal cord infarction
time Frame
From first dose of study medication to 30 days after last dose of study medication.

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Preserved source evidence · Not medical advice