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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
NCT ID:
NCT02167893
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
Frequency Threshold:
2
Time Frame:
Baseline up to 96 weeks
Study:
NCT02167893
Study Brief:
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Leuprorelin Acetate | Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed. | None | None | 188 | 11125 | 1429 | 11125 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Pseudomonas infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Bile duct cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Gastrointestinal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Tongue neoplasm malignant stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Facial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Pulmonary infarction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | Medra (17.0) | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | Medra (17.0) | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Medra (17.0) | View |
| Generalised erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Medra (17.0) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Medra (17.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Medra (17.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Medra (17.0) | View |
| Crepitations | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Cardiac pacemaker insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Medra (17.0) | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Medra (17.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Laryngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Metastases to lymph nodes | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Prostate cancer stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| T-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Large intestine carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Lip and/or oral cavity cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Marasmus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Medra (17.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Medra (17.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Medra (17.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Medra (17.0) | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cerebellar haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cerebrovascular disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Dyslalia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Hemiplegia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Hyperreflexia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Optic neuritis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Thrombotic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Medra (17.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | Medra (17.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardiomegaly | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Prinzmetal angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Ventricular hypokinesia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Arteriosclerosis obliterans | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Aortic dissection rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | Medra (17.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Vocal cord polyp | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Nocturnal dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Medra (17.0) | View |
| Gallbladder perforation | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | Medra (17.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Medra (17.0) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | Medra (17.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site erosion | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site ulcer | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | Medra (17.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Chest X-ray abnormal | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Computerised tomogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Surfactant protein increased | SYSTEMATIC_ASSESSMENT | Investigations | Medra (17.0) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Medra (17.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Medra (17.0) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Medra (17.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Medra (17.0) | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Medra (17.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Injection site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Lung abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | Medra (17.0) | View |
Other Events(If Any):