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NCT00911859 · ADVERSE EVENTS

Adverse events

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients · Source last updated 2014-11-18

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 30 days after the last dose of study medication
Other-event reporting threshold
5%

For Safety analyses all randomized participants who received at least 1 dose of study agents were analyzed. Data are presented for 117 participants in the treatment period (Part 1 and Part 2) and 21 participants who entered maintenance period (after achieving partial response or better in the Part 2 treatment period while receiving VPM+siltuximab)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab

Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.

8 / 1212 / 12Not reported / Not reported
Part 2: VMP (Velcade+Melphalan+Prednisone)

Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.

27 / 5351 / 53Not reported / Not reported
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab

Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.

30 / 5251 / 52Not reported / Not reported
Part 2, Maintenance Period: Siltuximab

Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period

1 / 2115 / 21Not reported / Not reported

Group identifiers: EG000: Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab · EG001: Part 2: VMP (Velcade+Melphalan+Prednisone) · EG002: Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab · EG003: Part 2, Maintenance Period: 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 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Failure Acute
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardio-Respiratory Arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Myocardial Infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Steroid Withdrawal Syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Diarrhoea

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 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Conjunctivitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Dry Eye
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain Upper
Complete source fields
description
For Safety analyses all randomized participants who received at least 1 dose of study agents were analyzed. Data are presented for 117 participants in the treatment period (Part 1 and Part 2) and 21 participants who entered maintenance period (after achieving partial response or better in the Part 2 treatment period while receiving VPM+siltuximab)
event Groups
  1. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    8
    serious Num At Risk
    12
    title
    Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
  2. description
    Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    53
    serious Num Affected
    27
    serious Num At Risk
    53
    title
    Part 2: VMP (Velcade+Melphalan+Prednisone)
  3. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    EG002
    other Num Affected
    51
    other Num At Risk
    52
    serious Num Affected
    30
    serious Num At Risk
    52
    title
    Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
  4. description
    Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    21
    serious Num Affected
    1
    serious Num At Risk
    21
    title
    Part 2, Maintenance Period: Siltuximab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Conjunctivitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Dry Eye
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain Upper
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardiac Failure Acute
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Cardio-Respiratory Arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Myocardial Infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Steroid Withdrawal Syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Abdominal Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    term
    Diarrhoea
time Frame
Up to 30 days after the last dose of study medication

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Preserved source evidence · Not medical advice