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: 2025-12-24 @ 11:58 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT05896761
Description: All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
Frequency Threshold: 5
Time Frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
Study: NCT05896761
Study Brief: A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. 0 None 0 54 38 54 View
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks Thigh Injection Phase 0 None 0 64 46 64 View
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase Participants received first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q8W. 0 None 1 51 6 51 View
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase Participants received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. 0 None 0 61 11 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Injection site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View