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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT05359666
Description: The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
Frequency Threshold: 0
Time Frame: CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
Study: NCT05359666
Study Brief: Retrospective Independent Safety Review of Closed Irrisept Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Irrisept Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01. Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris. Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use. 7 None 63 294 157 294 View
Standard of Care (SoC) Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01. Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none. 8 None 93 298 101 298 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood/Lymphatic SAEs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac SAEs NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
General SAEs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hepatobiliary SAEs NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infection SAEs NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury SAEs NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nervous System SAEs NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric SAEs NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal/Urinary SAEs NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory SAEs NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear/Labyrinth SAEs NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Endocrine SAEs NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ocular SAEs NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Immune System SAEs NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Musculoskeletal SAEs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasm SAEs NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Reproductive System SAEs NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin/Subcutaneous Tissue SAEs NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
GI SAEs NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metabolic SAEs NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vascular SAEs NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Investigational SAEs NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood/Lymphatic AEs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac AEs NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear/Labyrinth AEs NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Endocrine AEs NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ocular AEs NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
GI AEs NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General AEs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hepatobiliary AEs NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infection AEs NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury AEs NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Investigational AEs NON_SYSTEMATIC_ASSESSMENT Investigations None View
Metabolic AEs NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal AEs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasm AEs NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous System AEs NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric AEs NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal/Urinary AEs NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive System AEs NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Respiratory AEs NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin/Subcutaneous Tissue AEs NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vascular AEs NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Adverse Device Effects NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View