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 @ 4:51 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT03382418
Description: "Other (Not Including Serious) Adverse Events" report participants who had adverse events (not including serious adverse events). Outcome measure 16 report participants who had serious adverse events (1 had, other 14 participants didn't have for Group 1: Vaccine Arm/Group; The participant who had a serious adverse event also had Other (Not Including Serious) Adverse Events; Thus 15 participants in Group 1: Vaccine Arm/Group had Other (Not Including Serious) Adverse Events).
Frequency Threshold: 0
Time Frame: Serious adverse events were collected through the month 12 timepoint. All other AEs were collected through 30 days after each vaccination. All-cause mortality were collected through Month 12.
Study: NCT03382418
Study Brief: Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States
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: Vaccine gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 0 None 1 25 15 25 View
Group 2: Vaccine gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 0 None 0 15 8 15 View
Group 3: Placebo Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6 0 None 0 5 4 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Any SOC NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Systemic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Any SOC NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Gingival swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Tooth impacted NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Body tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Papilloma viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.1 View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Respiratory symptom NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Any SOC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View