Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02639546 · ADVERSE EVENTS

Adverse events

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors · Source last updated 2022-09-16

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
Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I (Tablet) Cobimetinib (0.6 mg/kg)

Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 66 / 60 / 6
Phase I (Tablet) Cobimetinib (0.8 mg/kg)

Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 66 / 60 / 6
Phase I (Tablet) Cobimetinib (1 mg/kg)

Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 66 / 60 / 6
Phase I (Suspension) Cobimetinib (0.6 mg/kg)

Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 66 / 60 / 6
Phase I (Suspension) Cobimetinib (0.8 mg/kg)

Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

1 / 77 / 70 / 7
Phase I (Suspension) Cobimetinib (1 mg/kg)

Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 88 / 80 / 8
Phase I (Suspension) Cobimetinib (1.33 mg/kg)

Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

2 / 55 / 50 / 5
Phase II (Suspension) Cobimetinib (1 mg/kg)

Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

5 / 1212 / 120 / 12

Group identifiers: EG000: Phase I (Tablet) Cobimetinib (0.6 mg/kg) · EG001: Phase I (Tablet) Cobimetinib (0.8 mg/kg) · EG002: Phase I (Tablet) Cobimetinib (1 mg/kg) · EG003: Phase I (Suspension) Cobimetinib (0.6 mg/kg) · EG004: Phase I (Suspension) Cobimetinib (0.8 mg/kg) · EG005: Phase I (Suspension) Cobimetinib (1 mg/kg) · EG006: Phase I (Suspension) Cobimetinib (1.33 mg/kg) · EG007: Phase II (Suspension) Cobimetinib (1 mg/kg)

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
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Cardiac ventricular thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chorioretinopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Catheter site infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Gastroenteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Paronychia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Skin infection

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      12
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Iris hamartoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Precocious puberty
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chorioretinopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Conjunctivitis allergic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Corneal neovascularisation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Detachment of retinal pigment epithelium
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I (Tablet) Cobimetinib (0.6 mg/kg)
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I (Tablet) Cobimetinib (0.8 mg/kg)
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I (Tablet) Cobimetinib (1 mg/kg)
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I (Suspension) Cobimetinib (0.6 mg/kg)
  5. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Phase I (Suspension) Cobimetinib (0.8 mg/kg)
  6. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG005
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    2
    serious Num At Risk
    8
    title
    Phase I (Suspension) Cobimetinib (1 mg/kg)
  7. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG006
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase I (Suspension) Cobimetinib (1.33 mg/kg)
  8. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG007
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    Phase II (Suspension) Cobimetinib (1 mg/kg)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      12
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Iris hamartoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Precocious puberty
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chorioretinopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Conjunctivitis allergic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Corneal neovascularisation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Detachment of retinal pigment epithelium
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Cardiac ventricular thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Chorioretinopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Catheter site infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Gastroenteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Paronychia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      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
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Skin infection
time Frame
Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice