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 @ 12:31 AM
Ignite Modification Date: 2025-12-25 @ 10:38 PM
NCT ID: NCT02273167
Description: Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
Frequency Threshold: 1
Time Frame: Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Study: NCT02273167
Study Brief: Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MOVIPREP, 2-Day Split-Dosing MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). None None 0 263 31 263 View
NER1006, 2-Day Split-Dosing NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). None None 2 262 41 262 View
NER1006,1-Day Morning Split-Dosing NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy). None None 0 269 49 269 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Procedural intestinal perforation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
Alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View