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 @ 2:45 AM
Ignite Modification Date: 2025-12-26 @ 1:25 AM
NCT ID: NCT00655733
Description: None
Frequency Threshold: 5
Time Frame: From subject randomization through 8 weeks of treatment and through the 30 day follow up period following the date of the last dose of study drug was taken.
Study: NCT00655733
Study Brief: Phase II Study of HMPL-004 in Subjects With Crohn's Disease
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 Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up. 0 None 4 50 18 50 View
HMPL-004 Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up. 0 None 2 51 26 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v3.0 View
Female genital tract fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI-CTCAE v3.0 View
Lung squamous cell carcinoma stage unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) NCI-CTCAE v3.0 View
Crohn's disease (flare) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v3.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v3.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v3.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v3.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v3.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v3.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v3.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v3.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v3.0 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v3.0 View