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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT01165203
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
Study: NCT01165203
Study Brief: Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Group Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. 0 None 2 49 29 49 View
GSK1437173A Group Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. 0 None 6 74 72 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Laryngeal cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Drug abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Epididymitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Gastrointestinal SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Myalgia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Shivering SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Temperature SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View