Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
NCT ID:
NCT02793232
Description:
None
Frequency Threshold:
5
Time Frame:
Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Study:
NCT02793232
Study Brief:
Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | 0 | None | 0 | 8 | 1 | 8 | View |
| Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part A: PF-06751979 200 mg Fed | All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | 0 | None | 0 | 7 | 6 | 7 | View |
| Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | 0 | None | 0 | 12 | 10 | 12 | View |
| Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication | 0 | None | 0 | 9 | 8 | 9 | View |
| Part C: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | 0 | None | 0 | 2 | 2 | 2 | View |
| Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | 0 | None | 0 | 8 | 6 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Blepharospasm | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Conjunctival hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Hunger | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Vessel puncture site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Fungal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Atrioventricular block first degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Eye movement disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gingival pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Paraesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pulpitis dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Poor quality sleep | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Daydreaming | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Nightmare | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Dry throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Throat irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |