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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT03008460
Description: The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
Frequency Threshold: 2
Time Frame: Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
Study: NCT03008460
Study Brief: Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing 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
Eziclen®/Izinova® Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose). 0 None 4 124 111 124 View
Klean-Prep® Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose). 0 None 3 117 105 117 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View