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NCT03110562 · ADVERSE EVENTS

Adverse events

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2024-08-21

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
From date of randomization up to 45 months
Other-event reporting threshold
5%

In other adverse events section, System Organ Classes for SVD and VD arms were recorded as per MedDRA version 24.1 and remaining events were recorded as per MedDRA version 22.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SVd Arm: Selinexor + Bortezomib + Dexamethasone

Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study.

109 / 195193 / 19574 / 195
Vd Arm: Bortezomib + Dexamethasone

Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

79 / 204197 / 20482 / 204
SVdX Arm: Selinexor + Bortezomib + Dexamethasone

Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

28 / 6665 / 6637 / 66
SdX Arm: Selinexor + Dexamethasone

Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

7 / 1414 / 143 / 14

Group identifiers: EG000: SVd Arm: Selinexor + Bortezomib + Dexamethasone · EG001: Vd Arm: Bortezomib + Dexamethasone · EG002: SVdX Arm: Selinexor + Bortezomib + Dexamethasone · EG003: SdX Arm: Selinexor + Dexamethasone

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Cardiac failure congestive
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Atrioventricular block
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Bradycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Cardiac arrest

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    term
    Vomiting
Complete source fields
description
In other adverse events section, System Organ Classes for SVD and VD arms were recorded as per MedDRA version 24.1 and remaining events were recorded as per MedDRA version 22.0.
event Groups
  1. deaths Num Affected
    74
    deaths Num At Risk
    195
    description
    Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study.
    id
    EG000
    other Num Affected
    193
    other Num At Risk
    195
    serious Num Affected
    109
    serious Num At Risk
    195
    title
    SVd Arm: Selinexor + Bortezomib + Dexamethasone
  2. deaths Num Affected
    82
    deaths Num At Risk
    204
    description
    Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    EG001
    other Num Affected
    197
    other Num At Risk
    204
    serious Num Affected
    79
    serious Num At Risk
    204
    title
    Vd Arm: Bortezomib + Dexamethasone
  3. deaths Num Affected
    37
    deaths Num At Risk
    66
    description
    Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    EG002
    other Num Affected
    65
    other Num At Risk
    66
    serious Num Affected
    28
    serious Num At Risk
    66
    title
    SVdX Arm: Selinexor + Bortezomib + Dexamethasone
  4. deaths Num Affected
    3
    deaths Num At Risk
    14
    description
    Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    EG003
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    7
    serious Num At Risk
    14
    title
    SdX Arm: Selinexor + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Vision blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Visual impairment
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Cardiac failure congestive
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Atrioventricular block
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Bradycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      204
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
    term
    Cardiac arrest
time Frame
From date of randomization up to 45 months

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Preserved source evidence · Not medical advice