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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT00158860
Description: ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product. ITT population was used for reporting adverse event.
Frequency Threshold: 5
Time Frame: AEs were collected up to end of study (Day 168).
Study: NCT00158860
Study Brief: A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
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 Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. 0 None 4 128 75 128 View
Valaciclovir 1g QD Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. 1 None 3 255 138 255 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA version 9.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 9.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 9.1 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 9.1 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 9.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 9.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 9.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 9.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 9.1 View