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NCT01794520 · ADVERSE EVENTS

Adverse events

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10

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
All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
Other-event reporting threshold
5%

TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Venetoclax 300 mg

Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

1 / 66 / 61 / 6
Phase 1: Venetoclax 600 mg

Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

4 / 99 / 91 / 9
Phase 1: Venetoclax 900 mg

Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

3 / 66 / 61 / 6
Phase 1: Venetoclax 1200 mg

Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

3 / 99 / 90 / 9
Phase 1 Safety Expansion: Venetoclax 1200 mg

Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

15 / 3635 / 366 / 36
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

6 / 2019 / 201 / 20
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

16 / 3127 / 3122 / 31

Group identifiers: EG000: Phase 1: Venetoclax 300 mg · EG001: Phase 1: Venetoclax 600 mg · EG002: Phase 1: Venetoclax 900 mg · EG003: Phase 1: Venetoclax 1200 mg · EG004: Phase 1 Safety Expansion: Venetoclax 1200 mg · EG005: Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg · EG006: Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

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 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    HYPERVISCOSITY SYNDROME
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ATRIAL FIBRILLATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    SUPRAVENTRICULAR TACHYCARDIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    DYSPEPSIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    OESOPHAGITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    STOMATITIS

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      36
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      31
      num Events
      9
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    LEUKOCYTOSIS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      5
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    LYMPHOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      31
      num Events
      7
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      36
      num Events
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      4
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    SINUS TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    TACHYCARDIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    EAR PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    VERTIGO
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    CATARACT
Complete source fields
description
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Phase 1: Venetoclax 300 mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Phase 1: Venetoclax 600 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase 1: Venetoclax 900 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Phase 1: Venetoclax 1200 mg
  5. deaths Num Affected
    6
    deaths Num At Risk
    36
    description
    Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    EG004
    other Num Affected
    35
    other Num At Risk
    36
    serious Num Affected
    15
    serious Num At Risk
    36
    title
    Phase 1 Safety Expansion: Venetoclax 1200 mg
  6. deaths Num Affected
    1
    deaths Num At Risk
    20
    description
    Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    EG005
    other Num Affected
    19
    other Num At Risk
    20
    serious Num Affected
    6
    serious Num At Risk
    20
    title
    Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
  7. deaths Num Affected
    22
    deaths Num At Risk
    31
    description
    The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    EG006
    other Num Affected
    27
    other Num At Risk
    31
    serious Num Affected
    16
    serious Num At Risk
    31
    title
    Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      36
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      20
      num Events
      2
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      31
      num Events
      9
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    LEUKOCYTOSIS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      5
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    LYMPHOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      31
      num Events
      7
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      36
      num Events
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      4
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    SINUS TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    TACHYCARDIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    EAR PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    VERTIGO
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    CATARACT
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    HYPERVISCOSITY SYNDROME
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ATRIAL FIBRILLATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    SUPRAVENTRICULAR TACHYCARDIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    DYSPEPSIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    OESOPHAGITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    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
      9
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    STOMATITIS
time Frame
All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.

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Preserved source evidence · Not medical advice