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 @ 1:39 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT05828095
Description: None
Frequency Threshold: 0
Time Frame: Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Study: NCT05828095
Study Brief: A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group T2 INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6 0 None 0 10 10 10 View
Group T1 INO-6160 (2.0 mg) at months 0, 1, 3, 6 0 None 0 10 9 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDRA 27.1 View
Nausea (Solicited) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 28 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 27.1 View
Chills (Solicited) SYSTEMATIC_ASSESSMENT General disorders MEDRA 28 View
Fatigue (Solicited) SYSTEMATIC_ASSESSMENT General disorders MEDRA 28 View
Injection site erythema (Solicited) SYSTEMATIC_ASSESSMENT General disorders MEDRA 28 View
Injection site pain (Solicited) SYSTEMATIC_ASSESSMENT General disorders MEDRA 28 View
Injection site swelling (Solicited) SYSTEMATIC_ASSESSMENT General disorders MEDRA 28 View
Injection site vesicles NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA 27.1 View
Anal chlamydia infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Chlamydial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Body temperature increased (Solicited) SYSTEMATIC_ASSESSMENT Investigations MEDRA 28 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Arthralgia (Solicited) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA 28 View
Myalgia (Solicited) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA 28 View
Headache (Solicited) SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 28 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 27.1 View
Vulvovaginal ulceration NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDRA 27.1 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA 27.1 View