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NCT03169361 · ADVERSE EVENTS

Adverse events

NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma" · Source last updated 2023-12-07

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
Up to 24 Week (From start of administration to the end of 6 cycles)
Other-event reporting threshold
5.0%

At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded. The data reported are only serious and the other (not including serious) ADRs by events because only serious and the other ADRs were planned to be collected and assessed in this study. Seriousness of AEs by events was out of the scope for the data collection plan.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ixazomib 4 mg

The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.

193 / 742515 / 74211 / 742

Group identifiers: EG000: Ixazomib 4 mg

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 v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Bacteraemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      742
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Bronchopulmonary aspergillosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Escherichia sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      742
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      742
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      742
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia cytomegaloviral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia haemophilus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia influenzal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia staphylococcal

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 v22.0
    stats
    1. group Id
      EG000
      num Affected
      313
      num At Risk
      742
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      742
    term
    Neuropathy peripheral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      742
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      742
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      742
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      742
    term
    Rash
Complete source fields
description
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded. The data reported are only serious and the other (not including serious) ADRs by events because only serious and the other ADRs were planned to be collected and assessed in this study. Seriousness of AEs by events was out of the scope for the data collection plan.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    742
    description
    The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.
    id
    EG000
    other Num Affected
    515
    other Num At Risk
    742
    serious Num Affected
    193
    serious Num At Risk
    742
    title
    Ixazomib 4 mg
frequency Threshold
5.0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      313
      num At Risk
      742
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      742
    term
    Neuropathy peripheral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      178
      num At Risk
      742
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      742
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      742
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      742
    term
    Rash
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Bacteraemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      742
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Bronchopulmonary aspergillosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Escherichia sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      742
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      742
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      742
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia cytomegaloviral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia haemophilus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia influenzal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      742
    term
    Pneumonia staphylococcal
time Frame
Up to 24 Week (From start of administration to the end of 6 cycles)

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Preserved source evidence · Not medical advice