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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
NCT ID:
NCT05767905
Description:
Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Frequency Threshold:
5
Time Frame:
From screening up to Day 35.
Study:
NCT05767905
Study Brief:
A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.
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 1 PF-06821497 Form 1 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST). | 0 | None | 0 | 12 | 5 | 12 | View |
| Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet | 0 | None | 1 | 5 | 2 | 5 | View |
| Part 1 PF-06821497 Form 2 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet. | 0 | None | 0 | 12 | 4 | 12 | View |
| Part 1 PF-06821497 Form 3 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size). | 0 | None | 0 | 12 | 2 | 12 | View |
| Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet | 0 | None | 0 | 6 | 3 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Wrist fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eyelid pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v26.0 | View |
| abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.0 | View |
| Vessel puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.0 | View |
| Nail avulsion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Coagulation time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Disturbance in attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Urine odour abnormal | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.0 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.0 | View |