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: 2025-12-24 @ 7:08 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT00882557
Description: Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.
Frequency Threshold: 5
Time Frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).
Study: NCT00882557
Study Brief: Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sequence BA All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A). None None 0 8 1 8 View
Sequence AB All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B). None None 0 7 3 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View