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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT02241720
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02241720
Study Brief: Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regorafenib Treatment regorafenib None None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease Progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tracheoesophageal fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
deydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
maculopapular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View