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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT00575094
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00575094
Study Brief: Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator. None None 1 None 9 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver Dysfunction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Bilirubin conjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View