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NCT02347917 · ADVERSE EVENTS

Adverse events

A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma · Source last updated 2022-04-12

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
During a period from initial dosing of investigational drug to final evaluation in the follow-up observation period. up to 31 months for deaths, up to 11 months for Serious and Other (Not Including Serious) Adverse Events
Other-event reporting threshold
5%

Safety analysis population \[separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25)\]

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

0 / 44 / 42 / 4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

7 / 2424 / 2419 / 24
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

7 / 2525 / 2521 / 25

Group identifiers: EG000: MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) · EG001: MPM: BBI608 + Pem + CDDP (Phase 2 Part) · EG002: MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Enterocolitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Gastric ulcer
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bronchopneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Neuroendocrine carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Delirium
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Thrombosis

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 (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      24
      num Events
      15
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      25
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Vertigo positional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      24
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      24
      num Events
      22
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      25
      num Events
      22
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      8
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      24
      num Events
      54
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      25
      num Events
      55
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Faecal incontinence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    term
    Gastritis
Complete source fields
description
Safety analysis population \[separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25)\]
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
  2. deaths Num Affected
    19
    deaths Num At Risk
    24
    description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    EG001
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    7
    serious Num At Risk
    24
    title
    MPM: BBI608 + Pem + CDDP (Phase 2 Part)
  3. deaths Num Affected
    21
    deaths Num At Risk
    25
    description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    EG002
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    7
    serious Num At Risk
    25
    title
    MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      24
      num Events
      15
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      25
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Vertigo positional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      24
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      24
      num Events
      22
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      25
      num Events
      22
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      8
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      24
      num Events
      54
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      25
      num Events
      55
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Faecal incontinence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    term
    Gastritis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Enterocolitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Gastric ulcer
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bronchopneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Neuroendocrine carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Delirium
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Thrombosis
time Frame
During a period from initial dosing of investigational drug to final evaluation in the follow-up observation period. up to 31 months for deaths, up to 11 months for Serious and Other (Not Including Serious) Adverse Events

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Preserved source evidence · Not medical advice