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NCT00608907 · ADVERSE EVENTS

Adverse events

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) · Source last updated 2012-01-30

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
VELCADE

Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.

14 / 3028 / 30Not reported / Not reported
VELCADE + Rifampicin

Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.

5 / 1313 / 13Not reported / Not reported
VELCADE + Dexamethasone

Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.

7 / 1818 / 18Not reported / Not reported

Group identifiers: EG000: VELCADE · EG001: VELCADE + Rifampicin · EG002: VELCADE + 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiopulmonary Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Ventricular Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Intestinal Obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Upper Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Catheter Site Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Death

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 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      18
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      18
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Eye pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
    term
    Visual Acuity Reduced
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Abdominal Distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Epigastric discomfort
Complete source fields
event Groups
  1. description
    Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    30
    serious Num Affected
    14
    serious Num At Risk
    30
    title
    VELCADE
  2. description
    Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    5
    serious Num At Risk
    13
    title
    VELCADE + Rifampicin
  3. description
    Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
    id
    EG002
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    7
    serious Num At Risk
    18
    title
    VELCADE + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      18
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      18
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Eye pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
    term
    Visual Acuity Reduced
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Abdominal Distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Epigastric discomfort
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiopulmonary Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Ventricular Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Intestinal Obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Upper Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Catheter Site Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Death

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Preserved source evidence · Not medical advice