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: 2025-12-26 @ 5:20 PM
Ignite Modification Date: 2025-12-26 @ 5:20 PM
NCT ID: NCT03054506
Description: All participants of the study were assessed for adverse events throughout the duration of the study. Adverse events were recorded, logged, and reported to the IRB where applicable. In-person follow-up was arranged for participants experiencing an adverse event to monitor resolution of symptoms.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for each subject throughout the study duration, from study enrollment to final day in study (includes 9-day follow-up period). Study duration was approximately 46-59 days.
Study: NCT03054506
Study Brief: The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CSP01 Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. 0 None 0 20 1 20 View
Carboxymethylcellulose (CMC) Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. 0 None 0 11 0 11 View
Placebo Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. 0 None 0 9 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation and back pain caused by constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View