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NCT02268253 · ADVERSE EVENTS

Adverse events

Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF) · Source last updated 2025-01-06

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 1145 days
Other-event reporting threshold
5%

All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

1 / 11 / 10 / 1
Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

0 / 22 / 22 / 2
Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

23 / 3939 / 3926 / 39
Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

1 / 22 / 22 / 2
Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

1 / 11 / 11 / 1
Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

20 / 3635 / 3621 / 36
Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis

Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.

1 / 11 / 11 / 1

Group identifiers: EG000: Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia · EG001: Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia · EG002: Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia · EG003: Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis · EG004: Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis · EG005: Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis · EG006: Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Cardiopulmonary failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Abdominal wall haematoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Multiple organ dysfunction syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Hyperkalaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Urinary tract disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Dyspnoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pneumonitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Capillary leak syndrome

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 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
Complete source fields
description
All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia
  2. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia
  3. deaths Num Affected
    26
    deaths Num At Risk
    39
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG002
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    23
    serious Num At Risk
    39
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia
  4. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis
  5. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis
  6. deaths Num Affected
    21
    deaths Num At Risk
    36
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG005
    other Num Affected
    35
    other Num At Risk
    36
    serious Num Affected
    20
    serious Num At Risk
    36
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis
  7. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Cardiopulmonary failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Abdominal wall haematoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Multiple organ dysfunction syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Hyperkalaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Urinary tract disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Dyspnoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Pneumonitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      39
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      36
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    term
    Capillary leak syndrome
time Frame
Up to 1145 days

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Preserved source evidence · Not medical advice