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NCT03582033 · ADVERSE EVENTS

Adverse events

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma · Source last updated 2024-12-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment for Part A: up to 44 months (maximum follow up of 45 months); Part B: up to 33 months (maximum follow up of 34 months); Part C: up to 36 months (maximum follow up of 37 months) and Part D: up to 19 months (maximum follow up of 20 months)
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: SEA-BCMA 100mg

Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

1 / 22 / 21 / 2
Part A: SEA-BCMA 200mg

Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

1 / 22 / 21 / 2
Part A: SEA-BCMA 400mg

Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

2 / 22 / 22 / 2
Part A: SEA-BCMA 800mg

Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

3 / 76 / 74 / 7
Part A: SEA-BCMA 1600mg

Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

8 / 2218 / 2211 / 22
Part B: SEA-BCMA 1600mg

Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

5 / 2017 / 202 / 20
Part C: SEA-BCMA 1600mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

5 / 1210 / 126 / 12
Part C: SEA-BCMA 800mg and Dexamethasone

Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

3 / 65 / 61 / 6
Part C: SEA-BCMA 1600 mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

2 / 55 / 52 / 5
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

3 / 55 / 51 / 5

Group identifiers: EG000: Part A: SEA-BCMA 100mg · EG001: Part A: SEA-BCMA 200mg · EG002: Part A: SEA-BCMA 400mg · EG003: Part A: SEA-BCMA 800mg · EG004: Part A: SEA-BCMA 1600mg · EG005: Part B: SEA-BCMA 1600mg · EG006: Part C: SEA-BCMA 1600mg and Dexamethasone · EG007: Part C: SEA-BCMA 800mg and Dexamethasone · EG008: Part C: SEA-BCMA 1600 mg and Dexamethasone · EG009: Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone

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 v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cystic fibrosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Cholelithiasis obstructive

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 v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      22
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      12
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Deafness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tinnitus
Complete source fields
description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Part A: SEA-BCMA 100mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Part A: SEA-BCMA 200mg
  3. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Part A: SEA-BCMA 400mg
  4. deaths Num Affected
    4
    deaths Num At Risk
    7
    description
    Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Part A: SEA-BCMA 800mg
  5. deaths Num Affected
    11
    deaths Num At Risk
    22
    description
    Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG004
    other Num Affected
    18
    other Num At Risk
    22
    serious Num Affected
    8
    serious Num At Risk
    22
    title
    Part A: SEA-BCMA 1600mg
  6. deaths Num Affected
    2
    deaths Num At Risk
    20
    description
    Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG005
    other Num Affected
    17
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Part B: SEA-BCMA 1600mg
  7. deaths Num Affected
    6
    deaths Num At Risk
    12
    description
    Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    Part C: SEA-BCMA 1600mg and Dexamethasone
  8. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Part C: SEA-BCMA 800mg and Dexamethasone
  9. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Part C: SEA-BCMA 1600 mg and Dexamethasone
  10. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    EG009
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      22
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      12
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Deafness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tinnitus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cystic fibrosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
      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
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Cholelithiasis obstructive
time Frame
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment for Part A: up to 44 months (maximum follow up of 45 months); Part B: up to 33 months (maximum follow up of 34 months); Part C: up to 36 months (maximum follow up of 37 months) and Part D: up to 19 months (maximum follow up of 20 months)

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Preserved source evidence · Not medical advice