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NCT04299048 · ADVERSE EVENTS

Adverse events

Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14

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
From Day 1 up to Week 24
Other-event reporting threshold
5%

MedDRA 24.1 coding dictionary was applied for all AE tables. 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 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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PF-06946860 Q3W

During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.

4 / 1010 / 101 / 10

Group identifiers: EG000: PF-06946860 Q3W

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Cholecystitis acute
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Transaminases increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Malignant neoplasm 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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Monocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Thrombocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Conjunctival hyperaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Lacrimation increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Abdominal pain upper
Complete source fields
description
MedDRA 24.1 coding dictionary was applied for all AE tables. 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 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.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    PF-06946860 Q3W
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Monocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Thrombocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Conjunctival hyperaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Lacrimation increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Cholecystitis acute
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Transaminases increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Malignant neoplasm progression
time Frame
From Day 1 up to Week 24

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Preserved source evidence · Not medical advice