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 @ 2:09 PM
Ignite Modification Date:
2025-12-25 @ 12:50 PM
NCT ID:
NCT05907395
Description:
None
Frequency Threshold:
5
Time Frame:
Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
Study:
NCT05907395
Study Brief:
A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PF-07293893 300 mg: CRYS/Fasted Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fasted condition. | 0 | None | 0 | 6 | 2 | 6 | View |
| PF-07293893 300 mg: CRYS/Fed Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fed condition. | 0 | None | 0 | 5 | 3 | 5 | View |
| PF-07293893 300 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 300 mg in fasted condition. | 0 | None | 0 | 6 | 3 | 6 | View |
| PF-07293893 750 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 750 mg in fasted condition. | 0 | None | 0 | 6 | 3 | 6 | View |
| PF-07293893 750 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 750 mg in fasted condition. | 0 | None | 0 | 6 | 5 | 6 | View |
| PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 | Participants who received PF-07293893 SDD 750 mg in fasted condition. | 0 | None | 0 | 12 | 8 | 12 | View |
| PF-07293893 750 mg: SDD/Fed Cohort 3 | Participants received PF-07293893 SDD 750 mg in fed condition. | 0 | None | 0 | 6 | 2 | 6 | View |
| PF-07293893 900 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 900 mg in fasted condition. | 0 | None | 0 | 6 | 4 | 6 | View |
| PF-07293893 1200 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 1200 mg in fasted condition. | 0 | None | 0 | 6 | 3 | 6 | View |
| PF-07293893 1500 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 1500 mg in fasted condition. | 0 | None | 0 | 6 | 4 | 6 | View |
| Placebo: CRYS/Fasted Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fasted condition. | 0 | None | 0 | 2 | 2 | 2 | View |
| Placebo: CRYS/Fed Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fed condition. | 0 | None | 0 | 2 | 1 | 2 | View |
| Placebo: SDD/Fasted Combined for All Cohorts | Participants received placebo matched to PF-07293893 SDD in fasted condition. | 0 | None | 0 | 18 | 6 | 18 | View |
| Placebo: SDD/Fed Cohort 2 | Participants received placebo matched to PF-07293893 SDD in fed condition. | 0 | None | 0 | 2 | 1 | 2 | View |
| PF-07293893 100 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD100 mg in fasted condition. | 0 | None | 0 | 6 | 1 | 6 | View |
| PF-07293893 10 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 10 mg in fasted condition. | 0 | None | 0 | 6 | 1 | 6 | View |
| PF-07293893 30 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 30 mg in fasted condition. | 0 | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Aphthous ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrointestinal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Application site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Vessel puncture site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Head discomfort | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Throat irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Seborrhoeic dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |