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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT01968356
Description: On Treatment Day, prior to collection of the baseline, 10-minute, and 6-hour post-prep samples, the skin in each test area will be evaluated for indications of skin irritation (dryness, edema, erythema, rash), based on the Skin Irritation Rating Scale: 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected on treatment day (1 day), thus all AEs by definition would be treatment-emergent.
Study: NCT01968356
Study Brief: In-vivo Efficacy Study of Patient Preoperative Preps
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3M CHG/IPA Prep Tint Abdominal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Tint: Apply topically. 0 None 0 93 0 93 View
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. 0 None 0 97 0 97 View
Normal Saline Inguinal Region 0.9% normal saline with applicator Normal Saline: Apply topically. 0 None 0 31 0 31 View
3M CHG/IPA Prep Colorless Abdominal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. 0 None 0 101 0 101 View
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. 0 None 0 96 0 96 View
Normal Saline Abdominal Region 0.9% normal saline with applicator Normal Saline: Apply topically. 0 None 0 32 0 32 View
3M CHG/IPA Prep Colorless Inguinal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. 0 None 0 97 0 97 View
3M CHG/IPA Prep Tint Inguinal Region Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. 0 None 0 99 0 99 View
Serious Events(If Any):
Other Events(If Any):