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NCT04628780 · ADVERSE EVENTS

Adverse events

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors · Source last updated 2024-07-29

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
AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Other-event reporting threshold
5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PF-07209960 1 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.

3 / 44 / 41 / 4
PF-07209960 3 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.

3 / 42 / 41 / 4
PF-07209960 10 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.

1 / 43 / 41 / 4
PF-07209960 15 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.

1 / 33 / 31 / 3
PF-07209960 20 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.

13 / 1616 / 163 / 16
PF-07209960 30 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.

5 / 65 / 61 / 6

Group identifiers: EG000: PF-07209960 1 mg SC · EG001: PF-07209960 3 mg SC · EG002: PF-07209960 10 mg SC · EG003: PF-07209960 15 mg SC · EG004: PF-07209960 20 mg SC · EG005: PF-07209960 30 mg SC

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Duodenal ulcer
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Enterocolitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Disease progression

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Eosinophilia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Microcytic anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Hyperthyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
Complete source fields
description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    PF-07209960 1 mg SC
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    PF-07209960 3 mg SC
  3. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    PF-07209960 10 mg SC
  4. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    PF-07209960 15 mg SC
  5. deaths Num Affected
    3
    deaths Num At Risk
    16
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    13
    serious Num At Risk
    16
    title
    PF-07209960 20 mg SC
  6. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    PF-07209960 30 mg SC
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Eosinophilia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Microcytic anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Hyperthyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Duodenal ulcer
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Enterocolitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Disease progression
time Frame
AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.

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Preserved source evidence · Not medical advice