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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT02426918
Description: Safety population included all participants who received at least one dose of study medication.
Frequency Threshold: 5
Time Frame: 21 days after EOT (Day 33)
Study: NCT02426918
Study Brief: Study of Debio 1450 for Bacterial Skin Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Debio 1450 80 mg/120 mg BID Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID. None None 2 110 18 110 View
Debio 1450 160 mg/240 mg BID Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID. None None 1 107 29 107 View
Vancomycin/Linezolid BID Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID. None None 1 107 20 107 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View