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NCT03484702 · ADVERSE EVENTS

Adverse events

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27

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
Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
Other-event reporting threshold
5%

All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

19 / 4540 / 4532 / 45
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

8 / 3225 / 3222 / 32
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

2 / 1412 / 149 / 14
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

0 / 41 / 40 / 4
Cohort 5: Primary Central Nervous System Lymphoma

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

2 / 75 / 75 / 7
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

1 / 119 / 114 / 11

Group identifiers: EG000: Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy · EG001: Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy · EG002: Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 · EG003: Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma · EG004: Cohort 5: Primary Central Nervous System Lymphoma · EG005: Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting

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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Neutropenia
  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
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypercalcaemia of malignancy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Ulcerative keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Melaena

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
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Acquired antithrombin III deficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
    term
    Anaemia
  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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypofibrinogenaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      11
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      11
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Keratopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
Complete source fields
description
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
event Groups
  1. deaths Num Affected
    32
    deaths Num At Risk
    45
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    45
    serious Num Affected
    19
    serious Num At Risk
    45
    title
    Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
  2. deaths Num Affected
    22
    deaths Num At Risk
    32
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    32
    serious Num Affected
    8
    serious Num At Risk
    32
    title
    Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
  3. deaths Num Affected
    9
    deaths Num At Risk
    14
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    14
    serious Num Affected
    2
    serious Num At Risk
    14
    title
    Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
  4. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
  5. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Cohort 5: Primary Central Nervous System Lymphoma
  6. deaths Num Affected
    4
    deaths Num At Risk
    11
    description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    11
    serious Num Affected
    1
    serious Num At Risk
    11
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
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
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Acquired antithrombin III deficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
    term
    Anaemia
  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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypofibrinogenaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      11
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      11
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Keratopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Neutropenia
  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
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Hypercalcaemia of malignancy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Ulcerative keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
    term
    Melaena
time Frame
Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).

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