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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT03803605
Description: Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Frequency Threshold: 0
Time Frame: For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants.
Study: NCT03803605
Study Brief: Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Enrolled Participants Completing Step 1 (Visits 1 and 2) Participants meeting enrollment criteria who completed a Baseline leukapheresis procedure. 0 None 0 15 14 15 View
Participants Receiving VRC07-523LS + Vorinostat (VOR) (Step 2/Visits 3-13) Participants with a Baseline RCI \> 0.30 per million cells who received two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered) Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered) 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural hypertension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tissue infiltration SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Blood HIV RNA increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations None View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations None View
Athralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View