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: NCT02852005
Description: This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
Frequency Threshold: 0
Time Frame: Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
Study: NCT02852005
Study Brief: Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
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 1: Boost MVA/HIV62B mo(0,4) post HVTN 205 MMM 0 None 0 4 2 4 View
Group 2: Boost MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM 0 None 0 4 4 4 View
Group 3: Boost MVA/HIV62B mo(0,4) post HVTN 205 DDMM 0 None 0 6 3 6 View
Group 4: Boost MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM 0 None 0 6 2 6 View
Group 5: Boost AIDSVAX B/E mo(0,4) post HVTN 205 DDMM 0 None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Duodenogastric reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA 22.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Immune system disorders MEDRA 22.1 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA 22.1 View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 22.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 22.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 22.1 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA 22.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 22.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 22.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 22.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDRA 22.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDRA 22.1 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDRA 22.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 22.1 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 22.1 View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 22.1 View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Eye disorders MEDRA 22.1 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MEDRA 22.1 View
Any Event in SOC NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 22.1 View