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NCT02633059 · ADVERSE EVENTS

Adverse events

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-09-19

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 3 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Dose Level 0

Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg

0 / 44 / 40 / 4
Phase 1: Dose Level 1

Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg

3 / 77 / 70 / 7
Phase 1: Dose Level 2

Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg

0 / 44 / 40 / 4
Phase 2: Dose Level 1

Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg

6 / 1717 / 172 / 17

Group identifiers: EG000: Phase 1: Dose Level 0 · EG001: Phase 1: Dose Level 1 · EG002: Phase 1: Dose Level 2 · EG003: Phase 2: Dose Level 1

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 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Sepsis
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    White blood cell decreased
  10. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypercalcemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Neoplasms benign, mal, uncpec - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Peripheral sensory neuropathy

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
      4
      num At Risk
      4
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
      num Events
      26
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      10
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      17
      num Events
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Cardiac disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      18
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      17
      num Events
      15
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Gastroesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      17
      num Events
      21
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      8
    term
    Vomiting
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1: Dose Level 0
  2. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Phase 1: Dose Level 1
  3. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1: Dose Level 2
  4. deaths Num Affected
    2
    deaths Num At Risk
    17
    description
    Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    EG003
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    6
    serious Num At Risk
    17
    title
    Phase 2: Dose Level 1
frequency Threshold
0
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
      4
      num At Risk
      4
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
      num Events
      26
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      10
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      17
      num Events
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Cardiac disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      18
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      17
      num Events
      15
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Gastroesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      17
      num Events
      21
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      8
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Sepsis
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    White blood cell decreased
  10. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypercalcemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Neoplasms benign, mal, uncpec - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Peripheral sensory neuropathy
time Frame
Up to 3 years

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Preserved source evidence · Not medical advice