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NCT04145531 · ADVERSE EVENTS

Adverse events

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) · Source last updated 2023-11-18

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
Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.
Other-event reporting threshold
5%

A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: JZP-458 IM 25 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.

20 / 3331 / 331 / 33
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

57 / 8381 / 832 / 83
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

34 / 5148 / 510 / 51
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

40 / 6156 / 610 / 61

Group identifiers: EG000: Part A: JZP-458 IM 25 mg/m^2 (MWF) · EG001: Part A: JZP-458 IM 37.5 mg/m^2 (MWF) · EG002: Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) · EG003: Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      61
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Methaemoglobinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      61
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Nausea

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Periorbital oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      61
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Anal fissure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      61
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      61
    term
    Diarrhoea
Complete source fields
description
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    33
    description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    33
    serious Num Affected
    20
    serious Num At Risk
    33
    title
    Part A: JZP-458 IM 25 mg/m^2 (MWF)
  2. deaths Num Affected
    2
    deaths Num At Risk
    83
    description
    Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    EG001
    other Num Affected
    81
    other Num At Risk
    83
    serious Num Affected
    57
    serious Num At Risk
    83
    title
    Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
  3. deaths Num Affected
    0
    deaths Num At Risk
    51
    description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    EG002
    other Num Affected
    48
    other Num At Risk
    51
    serious Num Affected
    34
    serious Num At Risk
    51
    title
    Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
  4. deaths Num Affected
    0
    deaths Num At Risk
    61
    description
    Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    EG003
    other Num Affected
    56
    other Num At Risk
    61
    serious Num Affected
    40
    serious Num At Risk
    61
    title
    Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Periorbital oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      61
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Anal fissure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      61
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      61
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      61
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Methaemoglobinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      61
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      51
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Nausea
time Frame
Treatment-emergent adverse events were collected from date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months.

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Preserved source evidence · Not medical advice