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 @ 5:21 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT00974350
Description: None
Frequency Threshold: 5
Time Frame: Through study completion, approximately 14 days
Study: NCT00974350
Study Brief: A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: SABER-Bupivacaine 2.5 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once 0 None 3 44 44 44 View
Group 2: SABER-Bupivacaine 5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once 0 None 2 47 44 47 View
Group 3: SABER-Placebo 2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once 0 None 1 32 31 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome None Cardiac disorders None View
Postoperative wound complication None Injury, poisoning and procedural complications None View
Syncope None Nervous system disorders None View
Syncope vasovagal None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus None Skin and subcutaneous tissue disorders None View
Hypotension None Vascular disorders None View
Bradycardia None Cardiac disorders None View
Tinnitus None Ear and labyrinth disorders None View
Constipation None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Application site discoloration None General disorders None View
Incision site infection None Infections and infestations None View
Back pain None Musculoskeletal and connective tissue disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Nausea None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Dizziness None Nervous system disorders None View
Incision site oedema None Injury, poisoning and procedural complications None View