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 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
NCT ID:
NCT03541603
Description:
None
Frequency Threshold:
0
Time Frame:
6 weeks
Study:
NCT03541603
Study Brief:
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Levosimendan 2.5mg/mL Injectable Solution | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) Levosimendan: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion | 0 | None | 3 | 18 | 13 | 18 | View |
| Matching Placebo | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion | 0 | None | 1 | 19 | 8 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Cardiogenic Shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Infusion site hemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Infusion site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Cardiogenic shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Right ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Atypical pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Bacteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Bronchitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Device-related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Vascular access site pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Underdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Device infusion issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (21.0) | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (21.0) | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (21.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Lactic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Skin necrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Peripheral artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Venous thrombosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Vison blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.0) | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |