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 @ 4:31 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02646566
Description: Any AE that is serious, occurring during the relevant study period (from study drug administration to 7-day follow-up), irrespective of the treatment received by the subject, must be reported to the Pharmacovigilance provider within 24 hours
Frequency Threshold: 5
Time Frame: 7 days
Study: NCT02646566
Study Brief: Study of APD421 as PONV Treatment (Prior Prophylaxis)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
APD421 IV 5mg IV dose of APD421 5mg (IV dose)- was administered to each patient in a double-blind fashion, by slow IV push over about two minutes into a peripheral or central venous cannula. 0 None 6 237 64 237 View
APD421 IV 10mg IV dose of APD421 10mg (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula. 0 None 3 230 66 230 View
Placebo IV dose of Placebo (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula. 0 None 5 235 78 235 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anastomosis Insufficiency SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Non-infectious gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Unspecified Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Intra-abdominal Hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Intractable vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Post procedural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Abscess Presacral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Fatty tissue prolapse at the tempral lobe SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Numbness in the leg SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Postoperative rise in creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Post cholecystectomy bile leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Postoperative Ileus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View