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 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
NCT ID:
NCT05206604
Description:
None
Frequency Threshold:
5
Time Frame:
Baseline up to the end of follow up (ie, up to 44 days)
Study:
NCT05206604
Study Brief:
A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 PF-07295324 0.12% Ointment BID | Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 4 | 3 | 4 | View |
| Cohort 1 PF-07295324 Vehicle Ointment BID | Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 2 | 1 | 2 | View |
| Cohort 2 PF-07259955 2% Cream BID | Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 4 | 1 | 4 | View |
| Cohort 2 PF-07259955 Vehicle Cream BID | Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 2 | 1 | 2 | View |
| Cohort 3 PF-07295324 0.12% Ointment BID | Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 4 | 3 | 4 | View |
| Cohort 3 PF-07295324 Vehicle Ointment BID | Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 2 | 2 | 2 | View |
| Cohort 4 PF-07295324 0.12% Ointment QD | Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 4 | 2 | 4 | View |
| Cohort 4 PF-07295324 Vehicle Ointment QD | Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days. | 0 | None | 0 | 2 | 0 | 2 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site dryness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Application site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Application site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Application site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Application site papules | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Application site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Scratch | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Intertrigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Pseudofolliculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Skin hypopigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |