Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00401843 · ADVERSE EVENTS

Adverse events

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-11-19

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
Not reported
Other-event reporting threshold
5%

The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 - Bortezomib + Siltuximab

Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m\^2) during cycle 1.

10 / 2121 / 21Not reported / Not reported
Part 2 - Bortezomib + Placebo

Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.

44 / 139135 / 139Not reported / Not reported
Part 2 - Bortezomib + Siltuximab

Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.

47 / 142140 / 142Not reported / Not reported

Group identifiers: EG000: Part 1 - Bortezomib + Siltuximab · EG001: Part 2 - Bortezomib + Placebo · EG002: Part 2 - Bortezomib + Siltuximab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Cardiac Disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiac Failure Congestive
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiogenic Shock
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiopulmonary Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Left Ventricular Dysfunction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Ventricular Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Eye Swelling
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Retinal Detachment

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      142
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      142
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      142
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      83
      num At Risk
      142
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      142
    term
    Vertigo
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Chalazion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      142
    term
    Conjunctivitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    term
    Lacrimation Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      142
    term
    Abdominal Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      142
    term
    Abdominal Pain Upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    term
    Aphthous Stomatitis
Complete source fields
description
The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.
event Groups
  1. description
    Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m\^2) during cycle 1.
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    10
    serious Num At Risk
    21
    title
    Part 1 - Bortezomib + Siltuximab
  2. description
    Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
    id
    EG001
    other Num Affected
    135
    other Num At Risk
    139
    serious Num Affected
    44
    serious Num At Risk
    139
    title
    Part 2 - Bortezomib + Placebo
  3. description
    Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
    id
    EG002
    other Num Affected
    140
    other Num At Risk
    142
    serious Num Affected
    47
    serious Num At Risk
    142
    title
    Part 2 - Bortezomib + Siltuximab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      142
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      142
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      142
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      83
      num At Risk
      142
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      142
    term
    Vertigo
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Chalazion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      142
    term
    Conjunctivitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    term
    Lacrimation Increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      142
    term
    Abdominal Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      142
    term
    Abdominal Pain Upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    term
    Aphthous Stomatitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Cardiac Disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiac Failure Congestive
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiogenic Shock
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Cardiopulmonary Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Left Ventricular Dysfunction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Ventricular Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    term
    Eye Swelling
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      139
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      142
    term
    Retinal Detachment

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice