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NCT01706666 · ADVERSE EVENTS

Adverse events

Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant · Source last updated 2018-09-17

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A

Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

1 / 11 / 1Not reported / Not reported
Arm B

Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

0 / 11 / 1Not reported / Not reported
Arm C

Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.

1 / 11 / 1Not reported / Not reported

Group identifiers: EG000: Arm A · EG001: Arm B · EG002: Arm C

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
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypertension

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 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      13
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Injection site reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      9
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Peripheral sensory neuropathy
Complete source fields
event Groups
  1. description
    Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Arm A
  2. description
    Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Arm B
  3. description
    Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Arm C
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      13
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Injection site reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      10
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      9
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Peripheral sensory neuropathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypertension

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