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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT02066402
Description: None
Frequency Threshold: 2
Time Frame: From the start of study drug administration until last subject last visit.
Study: NCT02066402
Study Brief: Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tedizolid Phosphate (Sivextro, BAY119-2631) Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo None None 11 292 60 292 View
Linezolid Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days None None 8 297 63 297 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Haematoma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Gastroduodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Therapeutic product ineffective NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Infected bite NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Skin bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Soft tissue infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Stasis dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Skin bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Injection site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View