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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03738904
Description: Any unexpected or adverse event that may or may not have resulted in unplanned visit to the emergency department, clinic, or additional tests or procedures.
Frequency Threshold: 0
Time Frame: 30 days postoperatively
Study: NCT03738904
Study Brief: Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 (Multimodal ERAS) Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol 0 None 0 45 4 45 View
Arm 2 (Control) Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. Patients will be allowed to take oral acetaminophen and ibuprofen over the counter if needed but active narcotic-sparing pain management regimen will not be implemented Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements Daily mineral oil 1 table spoon if no bowel movement by POD2 until regu-lar bowel movements Standard of care: Oxcodone PO Ketorolac IV only (intraop) 0 None 0 44 2 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse event not resulting in significant morbidity or mortality SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View