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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT05225558
Description: All clinically significant medical conditions or abnormalities observed from the administration of the IP until TOC were collected as AEs. If an AE identified before the administration of the IP worsened in severity after the IP administration, it was collected as a new AE.
Frequency Threshold: 5
Time Frame: From IP administration to TOC (Test of Cure, 4 weeks after EOT*), approximately 10 weeks *EOT (End of treatment): up to 6 weeks
Study: NCT05225558
Study Brief: A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID Vancomycin: IV infusion per 2020 IDSA guideline * Intravenous Vancomycin dosed as per 2020 IDSA guideline * Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L. * Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin). Delpazolid: BID, PO 0 None 0 18 13 18 View
Monotherapy - Vancomycin IV Plus Placebo of Delpazolid Vancomycin: IV infusion per 2020 IDSA guideline * Intravenous Vancomycin dosed as per 2020 IDSA guideline * Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L. * Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin). Placebo of Delpazolid: BID, PO 1 None 1 20 16 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
end stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Melaena 0 [0] 2 (10.00) [2] SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Escherichia test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Myocardial rupture SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.0 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View