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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT03964493
Description: Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Frequency Threshold: 5
Time Frame: Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up.
Study: NCT03964493
Study Brief: TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial 0 None 2 39 11 39 View
TNP-2092 TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial 0 None 1 78 27 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MRSA bacteremia and worsening cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
left upper extremity abscess,dehydration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View