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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT01374802
Description: The subjects were required to spontaneously report any AEs. In addition, subjects were assessed regularly for AEs during the trial.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) occurring up to 9 days after first drug administration of DRV/r were assigned to the treatment DRV/r and AEs occurring up to 13 days after last drug administration of DRV/r+FDV were assigned to the combined treatment DRV/r+FDV.
Study: NCT01374802
Study Brief: Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Darunavir+Ritonavir oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily None None 0 14 7 14 View
Faldaprevir+Darunavir+Ritonavir oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day. None None 0 14 11 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 14.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 14.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 14.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 14.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 14.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA 14.0 View