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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT05291520
Description: None
Frequency Threshold: 5
Time Frame: SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Study: NCT05291520
Study Brief: A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult 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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. 0 None 0 8 8 8 View
Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks. 0 None 0 8 1 8 View
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Medical device site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Injection site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View