Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:28 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
NCT ID: NCT01054820
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
Study: NCT01054820
Study Brief: Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. None None 1 123 15 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Application site rash SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Application site pruritus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View