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 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
NCT ID:
NCT01438957
Description:
None
Frequency Threshold:
1
Time Frame:
Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
Study:
NCT01438957
Study Brief:
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | 0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose | 0 | None | 0 | 22 | 19 | 22 | View |
| Dexmedetomidine 0.25 mcg/kg | 1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 0 | None | 0 | 24 | 24 | 24 | View |
| Dexmedetomidine 0.5 mcg/kg | 3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 0 | None | 0 | 25 | 22 | 25 | View |
| Dexmedetomidine 1.0 mcg/kg | 6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 0 | None | 0 | 25 | 25 | 25 | View |
| Dexmedetomidine 0.067 mcg/kg | 0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 0 | None | 1 | 23 | 21 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vasculitides | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory depression | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Apnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Glossoptosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Faecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Erythemas | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urethral pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Bladder irritation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Bladder spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thirst | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Post procedural haematuria | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |