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 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT02239692
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Study: NCT02239692
Study Brief: A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PICOPREP Day-before Dosing Schedule Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution None None 0 70 4 70 View
PICOPREP Tailored Dosing Schedule Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution None None 1 125 14 125 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.0) View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Gilbert's syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (17.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View