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 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT00298233
Description: The study recorded only cumulative data (total number of AEs per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
Frequency Threshold: 0
Time Frame: Through Day 28 for severe influenza, and Day 180 for avian influenza.
Study: NCT00298233
Study Brief: High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double Dose Oseltamivir The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events. None None 1 165 37 165 View
Standard Dose Oseltamivir The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events. None None 0 161 38 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Septic shock SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO ATC View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO ATC View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO ATC View
multi-organ failures SYSTEMATIC_ASSESSMENT General disorders WHO ATC View
acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO ATC View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO ATC View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO ATC View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO ATC View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders WHO ATC View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO ATC View
Septic shock SYSTEMATIC_ASSESSMENT Cardiac disorders WHO ATC View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO ATC View
other SYSTEMATIC_ASSESSMENT General disorders WHO ATC View