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NCT03685591 · ADVERSE EVENTS

Adverse events

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors · Source last updated 2024-06-26

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

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

Collection time frame
Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
Other-event reporting threshold
5%

The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one 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 1A: PF-06952229 20mg Monotherapy

PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

0 / 11 / 10 / 1
Part 1A: PF-06952229 40mg Monotherapy

PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

0 / 11 / 10 / 1
Part 1A: PF-06952229 80mg Monotherapy

PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

0 / 11 / 10 / 1
Part 1A: PF-06952229 150mg Monotherapy

PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

3 / 54 / 51 / 5
Part 1A: PF-06952229 250mg Monotherapy

PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

3 / 1313 / 130 / 13
Part 1A: PF-06952229 375mg Monotherapy

PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

5 / 1716 / 170 / 17
Part 1A: PF-06952229 500mg Monotherapy

PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).

0 / 44 / 40 / 4
Part 1B: PF-06952229 250mg + Enzalutamide

PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.

0 / 44 / 40 / 4
Part 1B: PF-06952229 375mg + Enzalutamide

PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.

0 / 33 / 30 / 3

Group identifiers: EG000: Part 1A: PF-06952229 20mg Monotherapy · EG001: Part 1A: PF-06952229 40mg Monotherapy · EG002: Part 1A: PF-06952229 80mg Monotherapy · EG003: Part 1A: PF-06952229 150mg Monotherapy · EG004: Part 1A: PF-06952229 250mg Monotherapy · EG005: Part 1A: PF-06952229 375mg Monotherapy · EG006: Part 1A: PF-06952229 500mg Monotherapy · EG007: Part 1B: PF-06952229 250mg + Enzalutamide · EG008: Part 1B: PF-06952229 375mg + Enzalutamide

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 v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Haematemesis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Mouth haemorrhage
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Hepatic haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Fracture

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Eosinophilia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Lymph node pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Atrial flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Ear pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Adrenal insufficiency
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Ocular hyperaemia
Complete source fields
description
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one 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
    0
    deaths Num At Risk
    1
    description
    PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1A: PF-06952229 20mg Monotherapy
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1A: PF-06952229 40mg Monotherapy
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1A: PF-06952229 80mg Monotherapy
  4. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Part 1A: PF-06952229 150mg Monotherapy
  5. deaths Num Affected
    0
    deaths Num At Risk
    13
    description
    PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG004
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Part 1A: PF-06952229 250mg Monotherapy
  6. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG005
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    5
    serious Num At Risk
    17
    title
    Part 1A: PF-06952229 375mg Monotherapy
  7. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Part 1A: PF-06952229 500mg Monotherapy
  8. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Part 1B: PF-06952229 250mg + Enzalutamide
  9. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Part 1B: PF-06952229 375mg + Enzalutamide
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Eosinophilia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Lymph node pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Atrial flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Ear pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Adrenal insufficiency
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Ocular hyperaemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Haematemesis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Mouth haemorrhage
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Hepatic haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Fracture
time Frame
Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)

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Preserved source evidence · Not medical advice