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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
NCT ID:
NCT02396758
Description:
None
Frequency Threshold:
0
Time Frame:
From Baseline up to Day 365
Study:
NCT02396758
Study Brief:
Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 2 mg/hour \[hr\]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | None | 11 | 37 | 9 | 37 | View |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | None | 15 | 37 | 22 | 37 | View |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 0 | None | 12 | 37 | 10 | 37 | View |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | None | 4 | 18 | 6 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster disseminated | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Anticoagulation drug level below therapeutic | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myeloproliferative disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary infarction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin necrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Post thrombotic syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Aneamia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anaemia postoperative | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Intra-abdominal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary alveolar haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anaemia postoperative | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Antithrombin III deficiency | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gravitational oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vessel puncture site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Coagulation factor VIII level increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Heart rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Postoperative renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Withdrawl bleed | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |