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 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
NCT ID:
NCT01811732
Description:
AE data are only included for the safety population which included all patients in the ITT population who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected from the time the patient signed the ICF through the follow-up telephone contact 30 days after the last dose of study drug (up to 45 days).
Study:
NCT01811732
Study Brief:
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure 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 |
|---|---|---|---|---|---|---|---|---|
| Delafloxacin Plus Placebo | 300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo | 1 | None | 12 | 324 | 91 | 324 | View |
| Vancomycin Plus Aztreonam + Placebo | Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo | 1 | None | 12 | 326 | 111 | 326 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Hepatitis C | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Septic Shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Skin bacterial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Polysubstance dependence | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Substance-induced mood disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastric ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pyoderma gangrenosum | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Hepatic cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Stab wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Soft tissue necrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Cervical radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Peripheral ischemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Peripheral vascular disorder | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |