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 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT01657292
Description: None
Frequency Threshold: 5
Time Frame: Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
Study: NCT01657292
Study Brief: Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Entire Study Population - Systemic AEs All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm. None None 2 61 0 61 View
Oleogel-S10 Localized AE All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm. None None 1 61 0 61 View
Octenilin Localized AE All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm. None None 1 61 0 61 View
Localized AE Both Wound Halves All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm. None None 4 61 0 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tonsil cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (15.1) View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.1) View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
Wound necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Other Events(If Any):