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NCT01318902 · ADVERSE EVENTS

Adverse events

Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis · Source last updated 2020-04-01

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 of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)
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 Cohort: Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.

3 / 66 / 60 / 6
Dose Escalation Cohort: Ixazomib 5.5 mg

Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.

5 / 55 / 50 / 5
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)

Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.

5 / 55 / 51 / 5
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)

Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.

5 / 1110 / 110 / 11

Group identifiers: EG000: Dose Escalation Cohort: Ixazomib 4.0 mg · EG001: Dose Escalation Cohort: Ixazomib 5.5 mg · EG002: Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) · EG003: Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)

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
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with Dose Expansion Cohort: Ixazomib 4 mg (PI Naive) and is not related.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Basal cell carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cholecystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Diarrhoea

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      11
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Decreased appetite
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Insomnia
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
    6
    description
    Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Dose Escalation Cohort: Ixazomib 4.0 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Dose Escalation Cohort: Ixazomib 5.5 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
  4. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      11
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Decreased appetite
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Insomnia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with Dose Expansion Cohort: Ixazomib 4 mg (PI Naive) and is not related.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Basal cell carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cholecystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Diarrhoea
time Frame
From the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)

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Preserved source evidence · Not medical advice