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NCT03037385 · ADVERSE EVENTS

Adverse events

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors · Source last updated 2025-05-31

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
AEs and SAEs: From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years) All-cause Mortality: Up to approximately 7 years Safety population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels.
Other-event reporting threshold
5%

As pre-specified in SAP, safety data was to be analyzed \& reported per pre-planned grouped dose level II. Per dose level II, ≤ 300 mg QD arm included participants dosed with pralsetinib at 30 mg, 60 mg , 100 mg , 200 mg \& 300 mg QD; 400 mg arm included participants dosed at 400 mg QD, BID Dosing Schedule arm included participants dosed with 100/100 mg \& 200/100 mg BID, \& All doses included participants treated at all QD \& BID doses \& 600 mg QD dose. Hence, AEs cannot be presented per dose level.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pralsetinib ≤ 300 mg QD

Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.

26 / 3736 / 3715 / 37
Pralsetinib 400 mg QD

Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.

381 / 540536 / 540245 / 540
Pralsetinib BID Dosing Schedule

Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons.

7 / 99 / 97 / 9
Pralsetinib All Doses

Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons.

416 / 590585 / 590268 / 590

Group identifiers: EG000: Pralsetinib ≤ 300 mg QD · EG001: Pralsetinib 400 mg QD · EG002: Pralsetinib BID Dosing Schedule · EG003: Pralsetinib All Doses

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      540
      num Events
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      590
      num Events
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Anaemia of malignant disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Blood loss anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      2
    term
    Disseminated intravascular coagulation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      2
    term
    Eosinophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      540
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      590
      num Events
      6
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      3
    term
    Leukocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      540
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      590
      num Events
      11
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      540
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Pancytopenia

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
      num Events
      45
    2. group Id
      EG001
      num Affected
      285
      num At Risk
      540
      num Events
      1098
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      9
      num Events
      15
    4. group Id
      EG003
      num Affected
      310
      num At Risk
      590
      num Events
      1168
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      11
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      540
      num Events
      226
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      590
      num Events
      239
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
      num Events
      29
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      540
      num Events
      321
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      8
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      590
      num Events
      359
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      37
      num Events
      22
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      540
      num Events
      422
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      135
      num At Risk
      590
      num Events
      456
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      6
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      540
      num Events
      98
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      590
      num Events
      105
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Left ventricular dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Left ventricular hypertrophy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Corneal epithelial microcysts
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Eye disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      540
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      590
      num Events
      5
    term
    Growth of eyelashes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      540
      num Events
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      590
      num Events
      52
    term
    Vision blurred
Complete source fields
description
As pre-specified in SAP, safety data was to be analyzed \& reported per pre-planned grouped dose level II. Per dose level II, ≤ 300 mg QD arm included participants dosed with pralsetinib at 30 mg, 60 mg , 100 mg , 200 mg \& 300 mg QD; 400 mg arm included participants dosed at 400 mg QD, BID Dosing Schedule arm included participants dosed with 100/100 mg \& 200/100 mg BID, \& All doses included participants treated at all QD \& BID doses \& 600 mg QD dose. Hence, AEs cannot be presented per dose level.
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    37
    description
    Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    37
    serious Num Affected
    26
    serious Num At Risk
    37
    title
    Pralsetinib ≤ 300 mg QD
  2. deaths Num Affected
    245
    deaths Num At Risk
    540
    description
    Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
    id
    EG001
    other Num Affected
    536
    other Num At Risk
    540
    serious Num Affected
    381
    serious Num At Risk
    540
    title
    Pralsetinib 400 mg QD
  3. deaths Num Affected
    7
    deaths Num At Risk
    9
    description
    Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons.
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Pralsetinib BID Dosing Schedule
  4. deaths Num Affected
    268
    deaths Num At Risk
    590
    description
    Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons.
    id
    EG003
    other Num Affected
    585
    other Num At Risk
    590
    serious Num Affected
    416
    serious Num At Risk
    590
    title
    Pralsetinib All Doses
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
      num Events
      45
    2. group Id
      EG001
      num Affected
      285
      num At Risk
      540
      num Events
      1098
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      9
      num Events
      15
    4. group Id
      EG003
      num Affected
      310
      num At Risk
      590
      num Events
      1168
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      11
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      540
      num Events
      226
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      590
      num Events
      239
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      37
      num Events
      29
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      540
      num Events
      321
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      8
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      590
      num Events
      359
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      37
      num Events
      22
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      540
      num Events
      422
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      135
      num At Risk
      590
      num Events
      456
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      6
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      540
      num Events
      98
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      590
      num Events
      105
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Left ventricular dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Left ventricular hypertrophy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Corneal epithelial microcysts
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Eye disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      540
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      590
      num Events
      5
    term
    Growth of eyelashes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      540
      num Events
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      590
      num Events
      52
    term
    Vision blurred
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      540
      num Events
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      590
      num Events
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Anaemia of malignant disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Blood loss anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      2
    term
    Disseminated intravascular coagulation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      2
    term
    Eosinophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      540
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      590
      num Events
      6
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      3
    term
    Leukocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      590
      num Events
      1
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      540
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      590
      num Events
      11
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      540
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      590
      num Events
      2
    term
    Pancytopenia
time Frame
AEs and SAEs: From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years) All-cause Mortality: Up to approximately 7 years Safety population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels.

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Preserved source evidence · Not medical advice