Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03105336 · ADVERSE EVENTS

Adverse events

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

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
Up to 85.6 months
Other-event reporting threshold
5%

All-cause mortality included Full Analysis Set, that included all enrolled participants. Adverse events Safety Analysis Set, that included all participants treated with any dose of study drug. Retreatment arms included the Safety-Retreatment Analysis Set, that included all participants with re-treatment of Axicabtagene Ciloleucel from Safety Analysis Set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Axicabtagene Ciloleucel: Follicular Lymphoma

Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

65 / 124123 / 12436 / 127
Axicabtagene Ciloleucel: Marginal Zone Lymphoma

Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

19 / 2828 / 288 / 31
Axicabtagene Ciloleucel: Retreatment (FL)

Participants with r/r iNHL subtype of FL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10\^6 anti-CD19 CAR transduced autologous T, once at any time during the study.

5 / 1413 / 145 / 14
Axicabtagene Ciloleucel: Retreatment (MZL)

Participants with r/r iNHL subtype of MZL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10\^6 anti-CD19 CAR transduced autologous T, once at any time during the study.

1 / 22 / 20 / 2

Group identifiers: EG000: Axicabtagene Ciloleucel: Follicular Lymphoma · EG001: Axicabtagene Ciloleucel: Marginal Zone Lymphoma · EG002: Axicabtagene Ciloleucel: Retreatment (FL) · EG003: Axicabtagene Ciloleucel: Retreatment (MZL)

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Stress cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Blindness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Vision blurred

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    term
    Constipation
Complete source fields
description
All-cause mortality included Full Analysis Set, that included all enrolled participants. Adverse events Safety Analysis Set, that included all participants treated with any dose of study drug. Retreatment arms included the Safety-Retreatment Analysis Set, that included all participants with re-treatment of Axicabtagene Ciloleucel from Safety Analysis Set.
event Groups
  1. deaths Num Affected
    36
    deaths Num At Risk
    127
    description
    Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    EG000
    other Num Affected
    123
    other Num At Risk
    124
    serious Num Affected
    65
    serious Num At Risk
    124
    title
    Axicabtagene Ciloleucel: Follicular Lymphoma
  2. deaths Num Affected
    8
    deaths Num At Risk
    31
    description
    Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    19
    serious Num At Risk
    28
    title
    Axicabtagene Ciloleucel: Marginal Zone Lymphoma
  3. deaths Num Affected
    5
    deaths Num At Risk
    14
    description
    Participants with r/r iNHL subtype of FL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10\^6 anti-CD19 CAR transduced autologous T, once at any time during the study.
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Axicabtagene Ciloleucel: Retreatment (FL)
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants with r/r iNHL subtype of MZL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10\^6 anti-CD19 CAR transduced autologous T, once at any time during the study.
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Axicabtagene Ciloleucel: Retreatment (MZL)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Stress cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Blindness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    term
    Vision blurred
time Frame
Up to 85.6 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice