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NCT03248492 · ADVERSE EVENTS

Adverse events

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) · Source last updated 2025-06-26

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
Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
Other-event reporting threshold
5%

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: DS-8201a Low Dose

T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.

14 / 5050 / 5033 / 50
Part 1: DS-8201a Medium Dose

T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.

11 / 4848 / 4830 / 48
Part 1: DS-8201a High Dose

T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.

8 / 2121 / 2118 / 21
Part 2a: DS-8201a Low Dose

All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.

42 / 130129 / 13086 / 130
Part 2b (Exploratory): DS-8201a Low Dose

All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.

1 / 44 / 43 / 4

Group identifiers: EG000: Part 1: DS-8201a Low Dose · EG001: Part 1: DS-8201a Medium Dose · EG002: Part 1: DS-8201a High Dose · EG003: Part 2a: DS-8201a Low Dose · EG004: Part 2b (Exploratory): DS-8201a Low Dose

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 v20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Hematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Shock haemorrhagic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      130
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Abdominal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dysphagia

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 v20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      50
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Mitral valve incompetence
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Keratitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Lacrimation increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Visual impairment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    term
    Vomiting
Complete source fields
description
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
event Groups
  1. deaths Num Affected
    33
    deaths Num At Risk
    50
    description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    50
    serious Num Affected
    14
    serious Num At Risk
    50
    title
    Part 1: DS-8201a Low Dose
  2. deaths Num Affected
    30
    deaths Num At Risk
    48
    description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    EG001
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    11
    serious Num At Risk
    48
    title
    Part 1: DS-8201a Medium Dose
  3. deaths Num Affected
    18
    deaths Num At Risk
    21
    description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    EG002
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    8
    serious Num At Risk
    21
    title
    Part 1: DS-8201a High Dose
  4. deaths Num Affected
    86
    deaths Num At Risk
    130
    description
    All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
    id
    EG003
    other Num Affected
    129
    other Num At Risk
    130
    serious Num Affected
    42
    serious Num At Risk
    130
    title
    Part 2a: DS-8201a Low Dose
  5. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 2b (Exploratory): DS-8201a Low Dose
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      50
      num Events
      37
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Mitral valve incompetence
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Keratitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Lacrimation increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    term
    Visual impairment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Hematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Shock haemorrhagic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      130
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      130
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      130
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    term
    Abdominal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      130
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dysphagia
time Frame
Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.

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Preserved source evidence · Not medical advice