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 @ 1:40 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT05477095
Description: Definition does not differ.
Frequency Threshold: 5
Time Frame: Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Study: NCT05477095
Study Brief: A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy 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
UB-313 Cohort 3 UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12 UB-313: A synthetic peptide-based immunotherapy 0 None 0 8 6 8 View
UB-313 Cohort 4 UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 UB-313: A synthetic peptide-based immunotherapy 0 None 0 8 8 8 View
UB-313 Cohort 1 UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12 UB-313: A synthetic peptide-based immunotherapy 0 None 0 8 7 8 View
UB-313 Cohort 2 UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 UB-313: A synthetic peptide-based immunotherapy 0 None 0 8 8 8 View
Placebo Comparator Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12 Placebo: Normal saline 0 None 0 8 7 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View