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: 2025-12-25 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT02525133
Description: Subject 628-018 was randomized to the INL-001 group but received placebo; the subject was included in the INL-001 group for efficacy analyses (ie, ITT and mITT populations) and was included in the placebo group for safety analyses (ie, safety population). The ITT population consisted of all randomized subjects who may or may not have received any dose of INL-001 or placebo
Frequency Threshold: 5
Time Frame: 30 days
Study: NCT02525133
Study Brief: Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
XaraColl 3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose XaraColl: Surgical implantation of 3 bupivacaine collagen implants 0 None 3 208 118 208 View
Placebo 3 placebo implants Placebo: Plain collagen implant (vehicle) 1 None 3 107 76 107 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Incision site swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Incision site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View