Adverse Events Module

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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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT01359735
Description: All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Frequency Threshold: 0
Time Frame: Safety reporting occurred over the eight weeks of the study.
Study: NCT01359735
Study Brief: Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HP802-247 allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed None None 0 4 2 4 View
Bacitracin Ointment bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). None None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 12.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 12.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 12.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 12.0 View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 12.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 12.0 View