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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT00948818
Description: 803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
Frequency Threshold: 5
Time Frame: Adverse event data for the treatment period was collected from July of 2009 to July of 2010
Study: NCT00948818
Study Brief: Trial of Linaclotide Administered to Patients With 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
Placebo - Treatment Period Dose-matched placebo, oral administration, once per day. None None 2 396 22 396 View
Linaclotide - Treatment Period Linaclotide 290µg, oral administration, once per day. None None 2 406 93 406 View
Placebo to Linaclotide - Randomized Withdrawal Period Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period. This group had previously received dose-matched placebo during the 12-week randomized treatment period. None None 0 333 41 333 View
Linaclotide to Placebo - Randomized Withdrawal Period Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period. This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period. None None 0 154 1 154 View
Linaclotide to Linaclotide - Randomized Withdrawal Period Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period None None 0 158 5 158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View