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 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT01383005
Description: None
Frequency Threshold: 0
Time Frame: Collected at the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Study: NCT01383005
Study Brief: Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Overall Study Population HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to \<2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor. Also, HIV-infected participants treated with LPV/r from ≥3 months to \<2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD. None None 0 94 13 94 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Skin Disorders NOS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Sexual Disorder NOS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Burning Sensation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View