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NCT03288493 · ADVERSE EVENTS

Adverse events

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) · Source last updated 2024-03-28

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

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

Collection time frame
Baseline through Month 24
Other-event reporting threshold
5%

Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: P-BCMA-101 CAR-T Cells

Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.

39 / 6963 / 6923 / 69
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)

Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

1 / 33 / 30 / 3
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)

Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

1 / 11 / 10 / 1
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

7 / 87 / 83 / 8
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.

2 / 55 / 51 / 5
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

6 / 1616 / 160 / 16
Phase 2: P-BCMA-101 CAR-T Cells

CAR-T cells administered via intravenous infusion as a total dose

2 / 33 / 31 / 3
Retreatment

If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.

2 / 54 / 52 / 5

Group identifiers: EG000: Phase 1: P-BCMA-101 CAR-T Cells · EG001: Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) · EG002: Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) · EG003: Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) · EG004: Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) · EG005: Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) · EG006: Phase 2: P-BCMA-101 CAR-T Cells · EG007: Retreatment

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      69
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Bacterial sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Clostridium difficile infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Escherichia bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Influenza
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pancytopenia

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      69
      num Events
      189
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      12
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      16
      num Events
      32
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      69
      num Events
      132
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      8
      num Events
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      69
      num Events
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      16
      num Events
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
      num Events
      3
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      69
      num Events
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      8
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      69
      num Events
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      16
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      69
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      69
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      69
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      69
      num Events
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      8
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      16
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      69
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Oedema peripheral
Complete source fields
description
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    69
    description
    Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
    id
    EG000
    other Num Affected
    63
    other Num At Risk
    69
    serious Num Affected
    39
    serious Num At Risk
    69
    title
    Phase 1: P-BCMA-101 CAR-T Cells
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
  4. deaths Num Affected
    3
    deaths Num At Risk
    8
    description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
  5. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
  6. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    EG005
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    6
    serious Num At Risk
    16
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
  7. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    CAR-T cells administered via intravenous infusion as a total dose
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 2: P-BCMA-101 CAR-T Cells
  8. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Retreatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      69
      num Events
      189
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      12
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      16
      num Events
      32
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      69
      num Events
      132
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      8
      num Events
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      69
      num Events
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      16
      num Events
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
      num Events
      3
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      69
      num Events
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      8
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      69
      num Events
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      16
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      69
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      16
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      69
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      69
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      69
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      69
      num Events
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      8
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      16
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      69
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      69
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      69
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Bacterial sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Clostridium difficile infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Escherichia bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Influenza
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pancytopenia
time Frame
Baseline through Month 24

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Preserved source evidence · Not medical advice