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 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT01732692
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 0
Time Frame: From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours.
Study: NCT01732692
Study Brief: Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
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 (Morning-only Dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy. None None 0 70 41 70 View
MOVIPREP (Split-dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy. None None 0 70 43 70 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood chloride increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood iron decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood iron increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Product taste abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View