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 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
NCT ID:
NCT00917150
Description:
Safety analyses were conducted on the safety population, defined all randomized subjects who took at least one dose of the IMP. A TEAE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the IMP, regardless of judgment of relationship to the IMP.
Frequency Threshold:
2
Time Frame:
Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration until follow-up (2 weeks after the end of treatment or early termination)
Study:
NCT00917150
Study Brief:
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| OPC-6535 25 mg | Oral administration of 25mg OPC-6535 once daily for 24 months | 5 | None | 47 | 196 | 116 | 196 | View |
| Placebo | Oral administration of placebo once daily for 24 months | 2 | None | 46 | 190 | 105 | 190 | View |
| OPC-6535 12.5 mg | Oral administration of 12.5mg OPC-6535 once daily for 24 months | 1 | None | 47 | 192 | 108 | 192 | View |
| OPC-6535 50 mg | Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week) | 3 | None | 50 | 191 | 102 | 191 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Intraventricular haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Neuritis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Polyneuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Spinal meningeal cyst | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Subarachnoid haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Vertebrobasilar insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Dyssomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Ver. 12.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Pseudomembranous colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Pulmonary tuberculoma | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Joint injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Astrocytoma malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Bone neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Brain cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Chronic myelomonocytic leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Head and neck cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Hepatic cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Large cell lung cancer stage IV | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Large intestine carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Lung neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Neuroendocrine tumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Non-small cell lung cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Salivary gland neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Colonic polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Duodenal ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gastritis erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gingival cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Herpes zoster infection neurological | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Varicocele | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Ver. 12.0 | View |
| Computerised tomogram thorax abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 12.0 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 12.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Ver. 12.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Ver. 12.0 | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver. 12.0 | View |
| Chronic granulomatous disease | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Ver. 12.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Ver. 12.0 | View |
| Chronic obstructive pulmonary disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Hepatitis C | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Traumatic liver injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | View |
| Cor pulmonale | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Arteriosclerosis coronary artery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Cor pulmonale chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Hypertensive heart disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Ischaemic cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Prinzmetal angina | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Hypoxic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Chondromalacia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 12.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 12.0 | View |
| Hepatic cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 12.0 | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 12.0 | View |
| Cholangitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Ver. 12.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Ver. 12.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Ver. 12.0 | View |
| Dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Ver. 12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Ver. 12.0 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Ver. 12.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Ver. 12.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 12.0 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Ver. 12.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Ver. 12.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Ver. 12.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Ver. 12.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Ver. 12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Ver. 12.0 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Ver. 12.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Ver. 12.0 | View |