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NCT03639610 · ADVERSE EVENTS

Adverse events

PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function · Source last updated 2023-03-10

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
SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.
Other-event reporting threshold
0%

Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1a, Melflufen 40 mg

Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.

9 / 2120 / 2116 / 21
Cohort 1b, Melflufen 30 mg

Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.

5 / 1010 / 103 / 10
Cohort 2a, Melflufen 20 mg

Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.

0 / 43 / 41 / 4

Group identifiers: EG000: Cohort 1a, Melflufen 40 mg · EG001: Cohort 1b, Melflufen 30 mg · EG002: Cohort 2a, Melflufen 20 mg

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
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Catheter site haemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sudden cardiac death
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Septic shock
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Endocarditis bacterial
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Atrial fibrillation

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      21
      num Events
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      10
      num Events
      42
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
      num Events
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      21
      num Events
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      14
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Oesophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Toothache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Pyrexia
Complete source fields
description
Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. The median overall treatment duration for all patients was 25.57 weeks, and the duration of AE reporting is expected to be similar.
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    21
    description
    Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    9
    serious Num At Risk
    21
    title
    Cohort 1a, Melflufen 40 mg
  2. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Cohort 1b, Melflufen 30 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Cohort 2a, Melflufen 20 mg
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      21
      num Events
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      10
      num Events
      42
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      21
      num Events
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      21
      num Events
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      14
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Oesophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Toothache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Catheter site haemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sudden cardiac death
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Septic shock
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Endocarditis bacterial
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Atrial fibrillation
time Frame
SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer.

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Preserved source evidence · Not medical advice