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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:51 PM
NCT ID: NCT01807650
Description: None
Frequency Threshold: 5
Time Frame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Study: NCT01807650
Study Brief: Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
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 Adverse Events (AE) All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm. None None 4 112 30 112 View
Oleogel-S10 Localized Adverse Event (AE) All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm. None None 0 112 2 112 View
Non-adhesive Wound Dressing Localized AE All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated with non-adhesive wound dressing only are reported in this arm. None None 0 112 4 112 View
Localized AE Both Wound Halves All participants treated with Oleogel-S10 and non-adhesive wound dressing and non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one participant are reported in this arm. None None 1 112 9 112 View
Entire Study Population -Systemic and Localized AEs All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm. None None 5 112 40 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View