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 @ 12:20 PM
Ignite Modification Date:
2025-12-25 @ 12:03 PM
NCT ID:
NCT03344861
Description:
None
Frequency Threshold:
5
Time Frame:
Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
Study:
NCT03344861
Study Brief:
Safety of PDT-Photofrin® Prior to Lung Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length. | 0 | None | 4 | 10 | 10 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Deep Vein Thrombosis Left | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Hemorrhagic Shock | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Gastro-oesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Deep Vein Thrombosis (DVT) Right | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Swelling Face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Facial Blisters | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Forearm Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Hand Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Congenital diaphragmatic hernia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (17.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood alkaline phosphatase decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood creatinine decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| False negative investigation result | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hematocrit decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hematocrit increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Protein total decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Prothrombin time abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Red blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Red blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Respiratory rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| x-ray abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Protein deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Respiratory abnormal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Thoracic operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (17.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Blood Sodium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Facial erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Erythema on calves | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Abdomen erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood urea abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Chest x-ray abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Prothrombin time shortened | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |