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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT02637557
Description: Treatment-emergent adverse events (TEAEs) are presented. TEAEs are defined as adverse events (AEs) that started after the first dose of study drug or started before the first dose of study drug but increased in severity after the first dose of study drug. Safety population: all participants who were randomized and received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: From the first dose of study drug through Week 8/End-of-treatment (Day 57 + 3 days) plus 7 days.
Study: NCT02637557
Study Brief: A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
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 BID Matching placebo BID 0 None 2 70 16 70 View
500 mg IW-3718 BID 500 mg IW-3718 BID 0 None 1 71 17 71 View
1500 mg IW-3718 BID 1500 mg IW-3718 BID 0 None 2 68 12 68 View
1000 mg IW-3718 BID 1000 mg IW-3718 BID 0 None 1 71 19 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Selective abortion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View