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NCT02601950 · ADVERSE EVENTS

Adverse events

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma · Source last updated 2025-06-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Other-event reporting threshold
5%

Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rhabdoid Tumors: Cohort 1

Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

18 / 3227 / 329 / 32
Synovial Sarcoma: Cohort 2

Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

13 / 3328 / 332 / 33
Other INI1-Negative: Cohort 3

Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

11 / 3229 / 325 / 32
RMC: Cohort 4

Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

8 / 1412 / 143 / 14
ES: Cohort 5

Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

25 / 6258 / 628 / 62
ES Paired Biopsy: Cohort 6

Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

19 / 6965 / 696 / 69
Chordoma: Cohort 7

Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

7 / 1816 / 182 / 18
ES 1600 mg: Cohort 8

Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.

2 / 76 / 70 / 7

Group identifiers: EG000: Rhabdoid Tumors: Cohort 1 · EG001: Synovial Sarcoma: Cohort 2 · EG002: Other INI1-Negative: Cohort 3 · EG003: RMC: Cohort 4 · EG004: ES: Cohort 5 · EG005: ES Paired Biopsy: Cohort 6 · EG006: Chordoma: Cohort 7 · EG007: ES 1600 mg: Cohort 8

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      62
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      69
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dyspnoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Haemoptysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumothorax
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pulmonary embolism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Respiratory distress
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoxia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      62
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atelectasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      62
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Haemothorax

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      32
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      33
      num Events
      14
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      32
      num Events
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      62
      num Events
      31
    6. group Id
      EG005
      num Affected
      32
      num At Risk
      69
      num Events
      43
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      18
      num Events
      10
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      32
      num Events
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      14
      num Events
      6
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      62
      num Events
      23
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      69
      num Events
      13
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      18
      num Events
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      32
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
      num Events
      4
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      62
      num Events
      17
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      69
      num Events
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      62
      num Events
      15
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      69
      num Events
      17
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      18
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      18
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      33
      num Events
      13
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      32
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      62
      num Events
      38
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      69
      num Events
      26
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      18
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      6
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      69
      num Events
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      8
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      69
      num Events
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      18
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      33
      num Events
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      32
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      62
      num Events
      13
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      69
      num Events
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      33
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      32
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
      num Events
      4
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      62
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      9
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      69
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      7
      num Events
      8
    term
    Pleural effusion
Complete source fields
description
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    32
    description
    Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    32
    serious Num Affected
    18
    serious Num At Risk
    32
    title
    Rhabdoid Tumors: Cohort 1
  2. deaths Num Affected
    2
    deaths Num At Risk
    33
    description
    Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    33
    serious Num Affected
    13
    serious Num At Risk
    33
    title
    Synovial Sarcoma: Cohort 2
  3. deaths Num Affected
    5
    deaths Num At Risk
    32
    description
    Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG002
    other Num Affected
    29
    other Num At Risk
    32
    serious Num Affected
    11
    serious Num At Risk
    32
    title
    Other INI1-Negative: Cohort 3
  4. deaths Num Affected
    3
    deaths Num At Risk
    14
    description
    Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    14
    serious Num Affected
    8
    serious Num At Risk
    14
    title
    RMC: Cohort 4
  5. deaths Num Affected
    8
    deaths Num At Risk
    62
    description
    Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG004
    other Num Affected
    58
    other Num At Risk
    62
    serious Num Affected
    25
    serious Num At Risk
    62
    title
    ES: Cohort 5
  6. deaths Num Affected
    6
    deaths Num At Risk
    69
    description
    Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG005
    other Num Affected
    65
    other Num At Risk
    69
    serious Num Affected
    19
    serious Num At Risk
    69
    title
    ES Paired Biopsy: Cohort 6
  7. deaths Num Affected
    2
    deaths Num At Risk
    18
    description
    Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG006
    other Num Affected
    16
    other Num At Risk
    18
    serious Num Affected
    7
    serious Num At Risk
    18
    title
    Chordoma: Cohort 7
  8. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
    id
    EG007
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    ES 1600 mg: Cohort 8
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      32
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      33
      num Events
      14
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      32
      num Events
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      62
      num Events
      31
    6. group Id
      EG005
      num Affected
      32
      num At Risk
      69
      num Events
      43
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      18
      num Events
      10
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      32
      num Events
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      14
      num Events
      6
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      62
      num Events
      23
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      69
      num Events
      13
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      18
      num Events
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      32
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
      num Events
      4
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      62
      num Events
      17
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      69
      num Events
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      62
      num Events
      15
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      69
      num Events
      17
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      18
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      18
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      33
      num Events
      13
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      32
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      62
      num Events
      38
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      69
      num Events
      26
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      18
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      6
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      69
      num Events
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      8
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      69
      num Events
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      18
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      33
      num Events
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      32
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      62
      num Events
      13
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      69
      num Events
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      18
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      33
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      32
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      14
      num Events
      4
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      62
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      69
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
      num Events
      9
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      69
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      7
      num Events
      8
    term
    Pleural effusion
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      62
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      69
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dyspnoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      62
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Haemoptysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumothorax
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pulmonary embolism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Respiratory distress
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      69
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoxia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      62
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atelectasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      62
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      62
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      69
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      18
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Haemothorax
time Frame
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.

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