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NCT02573259 · ADVERSE EVENTS

Adverse events

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
Other-event reporting threshold
5%

The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

1 / 22 / 21 / 2
Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

3 / 87 / 86 / 8
Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

3 / 88 / 85 / 8
Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

3 / 77 / 76 / 7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

3 / 1515 / 1510 / 15
Part 1: PF-06801591 IV Total

Participants received PF-06801591 IV every 3 weeks for 21-day cycles in Part 1. (up to a maximum of of 233 weeks)

10 / 2524 / 2518 / 25
Part 1: PF-06801591 IV and SC Total

Participants received PF-06801591 IV every 3 weeks for 21-day cycles or SC every 4 weeks for 28-day cycles in Part 1. (up to a maximum of 233 weeks)

13 / 4039 / 4028 / 40
Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

18 / 6859 / 6833 / 68
Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)

13 / 3833 / 3821 / 38
Part 2: PF-06801591 NSCLC and UC Total

Participants with NSCLC or UC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles in Part 2. (up to a maximum of 126 weeks)

31 / 10692 / 10654 / 106

Group identifiers: EG000: Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) · EG001: Part 1: PF-06801591 1 mg/kg (IV) · EG002: Part 1: PF-06801591 3 mg/kg (IV) · EG003: Part 1: PF-06801591 10 mg/kg (IV) · EG004: Part 1: PF-06801591 300 mg (Subcutaneously [SC]) · EG005: Part 1: PF-06801591 IV Total · EG006: Part 1: PF-06801591 IV and SC Total · EG007: Part 2: PF-06801591 300 mg (SC) for NSCLC · EG008: Part 2: PF-06801591 300 mg (SC) for UC · EG009: Part 2: PF-06801591 NSCLC and UC Total

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Cardiac failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Cardiogenic shock
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Enteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Gastric ulcer haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Upper gastrointestinal haemorrhage

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      106
    term
    Atrial fibrillation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Bundle branch block
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Cardiac arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Myocardial ischaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Palpitations
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Tinnitus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      11
      num At Risk
      106
    term
    Hyperthyroidism
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      9
      num At Risk
      106
    term
    Hypothyroidism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Conjunctival haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Eye swelling
Complete source fields
description
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. deaths Num Affected
    10
    deaths Num At Risk
    15
    description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    EG004
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    3
    serious Num At Risk
    15
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  6. deaths Num Affected
    18
    deaths Num At Risk
    25
    description
    Participants received PF-06801591 IV every 3 weeks for 21-day cycles in Part 1. (up to a maximum of of 233 weeks)
    id
    EG005
    other Num Affected
    24
    other Num At Risk
    25
    serious Num Affected
    10
    serious Num At Risk
    25
    title
    Part 1: PF-06801591 IV Total
  7. deaths Num Affected
    28
    deaths Num At Risk
    40
    description
    Participants received PF-06801591 IV every 3 weeks for 21-day cycles or SC every 4 weeks for 28-day cycles in Part 1. (up to a maximum of 233 weeks)
    id
    EG006
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    13
    serious Num At Risk
    40
    title
    Part 1: PF-06801591 IV and SC Total
  8. deaths Num Affected
    33
    deaths Num At Risk
    68
    description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    EG007
    other Num Affected
    59
    other Num At Risk
    68
    serious Num Affected
    18
    serious Num At Risk
    68
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  9. deaths Num Affected
    21
    deaths Num At Risk
    38
    description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    EG008
    other Num Affected
    33
    other Num At Risk
    38
    serious Num Affected
    13
    serious Num At Risk
    38
    title
    Part 2: PF-06801591 300 mg (SC) for UC
  10. deaths Num Affected
    54
    deaths Num At Risk
    106
    description
    Participants with NSCLC or UC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles in Part 2. (up to a maximum of 126 weeks)
    id
    EG009
    other Num Affected
    92
    other Num At Risk
    106
    serious Num Affected
    31
    serious Num At Risk
    106
    title
    Part 2: PF-06801591 NSCLC and UC Total
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      106
    term
    Atrial fibrillation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Bundle branch block
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Cardiac arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Myocardial ischaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Palpitations
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Tinnitus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      11
      num At Risk
      106
    term
    Hyperthyroidism
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      9
      num At Risk
      106
    term
    Hypothyroidism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Conjunctival haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Eye swelling
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Cardiac failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Cardiogenic shock
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Enteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      106
    term
    Gastric ulcer haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      15
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      40
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      68
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      38
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      106
    term
    Upper gastrointestinal haemorrhage
time Frame
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).

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Preserved source evidence · Not medical advice