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 @ 2:50 PM
Ignite Modification Date:
2025-12-25 @ 1:17 PM
NCT ID:
NCT01076959
Description:
None
Frequency Threshold:
1
Time Frame:
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
Study:
NCT01076959
Study Brief:
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Humira | Patients who received Humira for 24 weeks during the PMDA review period. | None | None | 469 | 7740 | 863 | 7740 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tuberculosis gastrointestinal | None | Infections and infestations | MedDRA 14.0 | View |
| Right ventricular failure | None | Cardiac disorders | MedDRA 14.0 | View |
| Sick sinus syndrome | None | Cardiac disorders | MedDRA 14.0 | View |
| Deafness neurosensory | None | Ear and labyrinth disorders | MedDRA 14.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 14.0 | View |
| Retinal vein occlusion | None | Eye disorders | MedDRA 14.0 | View |
| Scleritis | None | Eye disorders | MedDRA 14.0 | View |
| Uveitis | None | Eye disorders | MedDRA 14.0 | View |
| Visual impairment | None | Eye disorders | MedDRA 14.0 | View |
| Colitis ischemic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Cerebellar infarction | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebral hemorrhage | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebral thrombosis | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebrovascular disorder | None | Nervous system disorders | MedDRA 14.0 | View |
| Demyelination | None | Nervous system disorders | MedDRA 14.0 | View |
| Nervous system disorder | None | Nervous system disorders | MedDRA 14.0 | View |
| Optic neuritis | None | Nervous system disorders | MedDRA 14.0 | View |
| Sciatica | None | Nervous system disorders | MedDRA 14.0 | View |
| Subarachnoid hemorrhage | None | Nervous system disorders | MedDRA 14.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 14.0 | View |
| Transient ischaemic attack | None | Nervous system disorders | MedDRA 14.0 | View |
| Putamen hemorrhage | None | Nervous system disorders | MedDRA 14.0 | View |
| Thrombotic cerebral infarction | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebral infarction | None | Nervous system disorders | MedDRA 14.0 | View |
| Completed suicide | None | Psychiatric disorders | MedDRA 14.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 14.0 | View |
| Calculus ureteric | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Nephrotic syndrome | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Renal failure | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Duodenal ulcer | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Enterocolitis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastric ulcer | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastric ulcer hemorrhage | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastric ulcer perforation | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastritis atrophic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastritis hemorrhagic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastrointestinal hemorrhage | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastrointestinal necrosis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Ileitis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Henoch-Schonlein purpura nephritis | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Interstitial lung disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Lung disorder | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Ileus paralytic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Intestinal obstruction | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Intestinal perforation | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Melena | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Esophageal ulcer | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Pancreatitis acute | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Peritonitis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Small intestine ulcer | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Upper gastrointestinal hemorrhage | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Duodenal stenosis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Pneumatosis intestinalis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diverticular perforation | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Chest pain | None | General disorders | MedDRA 14.0 | View |
| Death | None | General disorders | MedDRA 14.0 | View |
| Device breakage | None | General disorders | MedDRA 14.0 | View |
| Drowning | None | General disorders | MedDRA 14.0 | View |
| Gait disturbance | None | General disorders | MedDRA 14.0 | View |
| Hyperthermia | None | General disorders | MedDRA 14.0 | View |
| Local swelling | None | General disorders | MedDRA 14.0 | View |
| Malaise | None | General disorders | MedDRA 14.0 | View |
| Multiorgan failure | None | General disorders | MedDRA 14.0 | View |
| Edema | None | General disorders | MedDRA 14.0 | View |
| Edema peripheral | None | General disorders | MedDRA 14.0 | View |
| Pyrexia | None | General disorders | MedDRA 14.0 | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Cholecystitis acute | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Hepatic failure | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Hepatitis | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Jaundice | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Liver disorder | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Gallbladder polyp | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Anaphylactic reaction | None | Immune system disorders | MedDRA 14.0 | View |
| Anaphylactoid reaction | None | Immune system disorders | MedDRA 14.0 | View |
| Hypersensitivity | None | Immune system disorders | MedDRA 14.0 | View |
| Sarcoidosis | None | Immune system disorders | MedDRA 14.0 | View |
| Bronchiolitis | None | Infections and infestations | MedDRA 14.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 14.0 | View |
| Bronchopneumonia | None | Infections and infestations | MedDRA 14.0 | View |
| Bronchopulmonary aspergillosis | None | Infections and infestations | MedDRA 14.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA 14.0 | View |
| Cystitis | None | Infections and infestations | MedDRA 14.0 | View |
| Disseminated tuberculosis | None | Infections and infestations | MedDRA 14.0 | View |
| Endophthalmitis | None | Infections and infestations | MedDRA 14.0 | View |
| Erysipelas | None | Infections and infestations | MedDRA 14.0 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 14.0 | View |
| Hepatitis B | None | Infections and infestations | MedDRA 14.0 | View |
| Herpes zoster | None | Infections and infestations | MedDRA 14.0 | View |
| Infection | None | Infections and infestations | MedDRA 14.0 | View |
| Influenza | None | Infections and infestations | MedDRA 14.0 | View |
| Lymph node tuberculosis | None | Infections and infestations | MedDRA 14.0 | View |
| Meningitis | None | Infections and infestations | MedDRA 14.0 | View |
| Meningitis aseptic | None | Infections and infestations | MedDRA 14.0 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 14.0 | View |
| Peritonsillar abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia chlamydial | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia cytomegaloviral | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia legionella | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia pneumococcal | None | Infections and infestations | MedDRA 14.0 | View |
| Postoperative wound infection | None | Infections and infestations | MedDRA 14.0 | View |
| Pseudomembranous colitis | None | Infections and infestations | MedDRA 14.0 | View |
| Pulmonary tuberculosis | None | Infections and infestations | MedDRA 14.0 | View |
| Pulpitis dental | None | Infections and infestations | MedDRA 14.0 | View |
| Pyelonephritis | None | Infections and infestations | MedDRA 14.0 | View |
| Pyelonephritis acute | None | Infections and infestations | MedDRA 14.0 | View |
| Pyothorax | None | Infections and infestations | MedDRA 14.0 | View |
| Rash pustular | None | Infections and infestations | MedDRA 14.0 | View |
| Sepsis | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pulmonary edema | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Rheumatoid lung | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Diffuse panbronchiolitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Organising pneumonia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dermatitis acneiform | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Dermatitis allergic | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Shock | None | Vascular disorders | MedDRA 14.0 | View |
| Vasculitis | None | Vascular disorders | MedDRA 14.0 | View |
| Vasculitis necrotizing | None | Vascular disorders | MedDRA 14.0 | View |
| Deep vein thrombosis | None | Vascular disorders | MedDRA 14.0 | View |
| Arterial hemorrhage | None | Vascular disorders | MedDRA 14.0 | View |
| Agranulocytosis | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Anemia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Anemia folate deficiency | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Disseminated intravascular coagulation | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Lymphadenitis | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Lymphadenopathy | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Pancytopenia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Bone Marrow Failure | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA 14.0 | View |
| Angina pectoris | None | Cardiac disorders | MedDRA 14.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 14.0 | View |
| Atrial tachycardia | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac failure | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac failure acute | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 14.0 | View |
| Pericardial effusion | None | Cardiac disorders | MedDRA 14.0 | View |
| Septic shock | None | Infections and infestations | MedDRA 14.0 | View |
| Tonsillitis | None | Infections and infestations | MedDRA 14.0 | View |
| Tooth abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Tuberculosis | None | Infections and infestations | MedDRA 14.0 | View |
| Tuberculous pleurisy | None | Infections and infestations | MedDRA 14.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 14.0 | View |
| Muscle abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Abscess limb | None | Infections and infestations | MedDRA 14.0 | View |
| Arthritis bacterial | None | Infections and infestations | MedDRA 14.0 | View |
| Peritoneal tuberculosis | None | Infections and infestations | MedDRA 14.0 | View |
| Psoas abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Wound abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia bacterial | None | Infections and infestations | MedDRA 14.0 | View |
| Bursitis infective | None | Infections and infestations | MedDRA 14.0 | View |
| Lung infection | None | Infections and infestations | MedDRA 14.0 | View |
| Atypical mycobacterial infection | None | Infections and infestations | MedDRA 14.0 | View |
| Enterocolitis viral | None | Infections and infestations | MedDRA 14.0 | View |
| Purulence | None | Infections and infestations | MedDRA 14.0 | View |
| Mycobacterial infection | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumocystis jiroveci pneumonia | None | Infections and infestations | MedDRA 14.0 | View |
| Device related infection | None | Infections and infestations | MedDRA 14.0 | View |
| Enterocolitis bacterial | None | Infections and infestations | MedDRA 14.0 | View |
| Post procedural infection | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia cryptococcal | None | Infections and infestations | MedDRA 14.0 | View |
| Compression fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Femoral neck fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Femur fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fibula fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Foot fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fractured sacrum | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Head injury | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Pneumothorax traumatic | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Radius fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Rib fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Road traffic accident | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Spinal compression fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Subdural hematoma | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Tendon rupture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Tibia fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Ulna fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Joint injury | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Pelvic fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Periprosthetic fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Pubis fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA 14.0 | View |
| Blood glucose decreased | None | Investigations | MedDRA 14.0 | View |
| Blood glucose increased | None | Investigations | MedDRA 14.0 | View |
| Blood pressure increased | None | Investigations | MedDRA 14.0 | View |
| C-reactive protein increased | None | Investigations | MedDRA 14.0 | View |
| Carcinoembryonic antigen increased | None | Investigations | MedDRA 14.0 | View |
| Platelet count decreased | None | Investigations | MedDRA 14.0 | View |
| White blood cell count decreased | None | Investigations | MedDRA 14.0 | View |
| Blood beta-D-glucan abnormal | None | Investigations | MedDRA 14.0 | View |
| Hepatic enzyme increased | None | Investigations | MedDRA 14.0 | View |
| Cell marker increased | None | Investigations | MedDRA 14.0 | View |
| Candida test positive | None | Investigations | MedDRA 14.0 | View |
| Diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Arthropathy | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Bursitis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Myositis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Polymyalgia rheumatic | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Polymyositis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Rhabdomyolysis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Scleroderma | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Spinal column stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Systemic lupus erythematosus | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Foot deformity | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Spondylolisthesis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Atlantoaxial instability | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Rheumatoid arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Bile duct cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Bladder cancer recurrent | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Bone neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Breast cancer recurrent | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Cervix carcinoma stage IV | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Colon cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Gastric cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Hepatic neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Laryngeal cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Lung carcinoma cell type unspecified recurrent | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Lung squamous cell carcinoma stage unspecified | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Malignant ascites | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Meningioma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Non-Hodgkin's Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Rectal cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Squamous cell carcinoma of the cervix | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Tongue neoplasm malignant stage unspecified | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Tumour embolism | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Gallbladder cancer stage IV | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Large intestine carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Prostate cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Salivary gland neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Ovarian neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Metastatis | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Amnesia | None | Nervous system disorders | MedDRA 14.0 | View |
| Cauda equina syndrome | None | Nervous system disorders | MedDRA 14.0 | View |
| Pleurisy | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dermatomyositis | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Erythema | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Leukocytoclastic vasculitis | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash erythematosus | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash generalized | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Skin necrosis | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Skin ulcer | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Stevens-Johnson syndrome | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Generalized erythema | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Toxic skin eruption | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Dermatitis psoriasiform | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Aortic aneurysm | None | Vascular disorders | MedDRA 14.0 | View |
| Aortic dissection | None | Vascular disorders | MedDRA 14.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 14.0 | View |
| Peripheral circulatory failure | None | Vascular disorders | MedDRA 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | None | General disorders | MedDRA 14.0 | View |
| Injection site reaction | None | General disorders | MedDRA 14.0 | View |
| Pyrexia | None | General disorders | MedDRA 14.0 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 14.0 | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |