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NCT01645930 · ADVERSE EVENTS

Adverse events

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

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
First dose of study drug through 30 days after the last dose of study drug (up to 577 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
Ixazomib+Lenalidomide+Dexamethasone

Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)

18 / 4343 / 430 / 43

Group identifiers: EG000: Ixazomib+Lenalidomide+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
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Lung infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Diarrhoea infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Gastritis atrophic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Osteoporotic fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Plasmacytoma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Renal cell carcinoma

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 version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      43
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      43
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      43
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Abdominal pain upper
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. deaths Num Affected
    0
    deaths Num At Risk
    43
    description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    43
    serious Num Affected
    18
    serious Num At Risk
    43
    title
    Ixazomib+Lenalidomide+Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      43
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      43
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      43
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      43
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Lung infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Diarrhoea infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Gastritis atrophic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Osteoporotic fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    term
    Plasmacytoma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA version: 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    term
    Renal cell carcinoma
time Frame
First dose of study drug through 30 days after the last dose of study drug (up to 577 days)

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Preserved source evidence · Not medical advice