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: 2025-12-25 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:58 PM
NCT ID: NCT00786994
Description: None
Frequency Threshold: 3
Time Frame: Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
Study: NCT00786994
Study Brief: The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A - Oleogel-S10 Once Daily Oleogel-S10 ointment for three months once a day Oleogel-S10: topical use once or twice daily None None 2 57 3 57 View
B - Oleogel-S10 Twice Daily Oleogel-S10 vehicle for three months twice a day Oleogel-S10: topical use once or twice daily None None 3 54 7 54 View
C - Placebo Once Daily Placebo (petroleum jelly) for three months once a day Placebo (petroleum jelly) None None 0 26 3 26 View
D - Placebo Twice Daily Placebo (petroleum jelly) for three months twice a day Placebo (petroleum jelly) None None 0 28 3 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture of rib SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prolaps of intervertebral disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu-like syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastritis (including bile reflux gastritis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough / upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic reaction/hypersensitivity (including drug fever) SYSTEMATIC_ASSESSMENT Immune system disorders None View