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NCT00963820 · ADVERSE EVENTS

Adverse events

Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2018-01-10

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 the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation Cohorts

Ixazomib citrate, 0.24 to 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

7 / 3230 / 32Not reported / Not reported
Expansion Cohorts

Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

15 / 3131 / 31Not reported / Not reported

Group identifiers: EG000: Dose Escalation Cohorts · EG001: Expansion Cohorts

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Stenosis or Obstruction of Ileus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Hepatitis B
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
    term
    Abscess Neck
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Parainfluenzae virus infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Pneumonia respiratory syncytial viral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
    term
    Hypercalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
    term
    Dehydration

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 (15)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      31
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      31
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      31
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      31
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Chills
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
event Groups
  1. description
    Ixazomib citrate, 0.24 to 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    32
    serious Num Affected
    7
    serious Num At Risk
    32
    title
    Dose Escalation Cohorts
  2. description
    Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    15
    serious Num At Risk
    31
    title
    Expansion Cohorts
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      31
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      31
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      31
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      31
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Stenosis or Obstruction of Ileus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Hepatitis B
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
    term
    Abscess Neck
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Parainfluenzae virus infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Pneumonia respiratory syncytial viral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
    term
    Bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
    term
    Hypercalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
    term
    Dehydration
time Frame
From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)

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