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NCT02348216 · ADVERSE EVENTS

Adverse events

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma · Source last updated 2024-06-04

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
Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Other-event reporting threshold
5%

Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy

Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.

5 / 77 / 75 / 8
Phase 2 (Pivotal Study): Cohort 1

Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.

40 / 7777 / 7749 / 81
Phase 2 (Pivotal Study): Cohort 2

Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.

14 / 2423 / 2413 / 30
Phase 2 (Safety Management Study): Cohort 3

Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).

26 / 3838 / 3823 / 42
Phase 2 (Safety Management Study): Cohort 4

Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).

24 / 4141 / 4120 / 46
Phase 2 (Safety Management Study): Cohort 5

Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.

27 / 5050 / 5037 / 58
Phase 2 (Safety Management Study): Cohort 6

Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).

25 / 4040 / 4020 / 42
Retreatment Axicabtagene Ciloleucel: Phase 1

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.

1 / 11 / 11 / 1
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

5 / 99 / 98 / 9
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

1 / 22 / 22 / 2
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

2 / 22 / 21 / 2
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

0 / 22 / 22 / 2
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

0 / 22 / 22 / 2
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6

Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.

0 / 00 / 00 / 0

Group identifiers: EG000: Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy · EG001: Phase 2 (Pivotal Study): Cohort 1 · EG002: Phase 2 (Pivotal Study): Cohort 2 · EG003: Phase 2 (Safety Management Study): Cohort 3 · EG004: Phase 2 (Safety Management Study): Cohort 4 · EG005: Phase 2 (Safety Management Study): Cohort 5 · EG006: Phase 2 (Safety Management Study): Cohort 6 · EG007: Retreatment Axicabtagene Ciloleucel: Phase 1 · EG008: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1 · EG009: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2 · EG010: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3 · EG011: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4 · EG012: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5 · EG013: Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial flutter

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Acute left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
Complete source fields
description
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
  2. deaths Num Affected
    49
    deaths Num At Risk
    81
    description
    Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
    id
    EG001
    other Num Affected
    77
    other Num At Risk
    77
    serious Num Affected
    40
    serious Num At Risk
    77
    title
    Phase 2 (Pivotal Study): Cohort 1
  3. deaths Num Affected
    13
    deaths Num At Risk
    30
    description
    Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
    id
    EG002
    other Num Affected
    23
    other Num At Risk
    24
    serious Num Affected
    14
    serious Num At Risk
    24
    title
    Phase 2 (Pivotal Study): Cohort 2
  4. deaths Num Affected
    23
    deaths Num At Risk
    42
    description
    Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
    id
    EG003
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    26
    serious Num At Risk
    38
    title
    Phase 2 (Safety Management Study): Cohort 3
  5. deaths Num Affected
    20
    deaths Num At Risk
    46
    description
    Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
    id
    EG004
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    24
    serious Num At Risk
    41
    title
    Phase 2 (Safety Management Study): Cohort 4
  6. deaths Num Affected
    37
    deaths Num At Risk
    58
    description
    Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
    id
    EG005
    other Num Affected
    50
    other Num At Risk
    50
    serious Num Affected
    27
    serious Num At Risk
    50
    title
    Phase 2 (Safety Management Study): Cohort 5
  7. deaths Num Affected
    20
    deaths Num At Risk
    42
    description
    Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
    id
    EG006
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    25
    serious Num At Risk
    40
    title
    Phase 2 (Safety Management Study): Cohort 6
  8. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.
    id
    EG007
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Retreatment Axicabtagene Ciloleucel: Phase 1
  9. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
    id
    EG008
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1
  10. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
    id
    EG009
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2
  11. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
    id
    EG010
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3
  12. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
    id
    EG011
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Acute left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      77
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      50
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      2
    term
    Atrial flutter
time Frame
Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.

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Preserved source evidence · Not medical advice