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 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
NCT ID:
NCT01412333
Description:
The safety population included all participants who received any study drug.
Frequency Threshold:
5
Time Frame:
Baseline to approximately 588 weeks
Study:
NCT01412333
Study Brief:
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Interferon Beta-1a + Ocrelizumab Placebo (Double Blind) | Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). | 1 | None | 40 | 417 | 357 | 417 | View |
| Interferon Beta-1a + Ocrelizumab Placebo (Double Blind) Ocrelizumab (Open Label) | In DB phase participants received Interferon Beta-1a and Ocrelizumab Placebo. During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks. | 5 | None | 71 | 297 | 266 | 297 | View |
| Ocrelizumab + Interferon Beta-1a Placebo (Double Blind) Ocrelizumab (Open Label) | In DB phase participants received Ocrelizumab + Interferon Beta-1a Placebo. During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks. | 6 | None | 121 | 350 | 317 | 350 | View |
| Ocrelizumab + Interferon Beta-1a Placebo (Double Blind) | Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week. | 1 | None | 29 | 417 | 360 | 417 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| ENTEROVESICAL FISTULA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| HEPATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| HEPATITIS FULMINANT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| PNEUMOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| INCISIONAL HERNIA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| METASTATIC MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| DEPRESSION SUICIDAL | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| DEPRESSIVE DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| SPLENIC INFARCTION | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| SPLENIC VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| SPONTANEOUS HAEMATOMA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| TRISOMY 21 | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 25.1 | View |
| GOITRE | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 25.1 | View |
| THYROIDITIS SUBACUTE | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 25.1 | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| APPENDICITIS NONINFECTIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| CROHN'S DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| GASTROINTESTINAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| ILEUS PARALYTIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| MECHANICAL ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| PANCREATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| BILE DUCT STENOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| LIVER DISORDER | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ACUTE HEPATITIS C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ACUTE SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ANAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ATYPICAL PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CELLULITIS PHARYNGEAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CHOLECYSTITIS INFECTIVE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CHRONIC SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ENCEPHALITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ENTEROCOCCAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ENTEROVIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| FURUNCLE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| GASTRITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| INJECTION SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| LYME DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| MASTOIDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| MENINGITIS ASEPTIC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| MENINGITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ORCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| OTITIS MEDIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PARASITIC GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PASTEURELLA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PELVIC INFLAMMATORY DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PERIRECTAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA HAEMOPHILUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PYURIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| STAPHYLOCOCCAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| TOOTH INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| VIRAL PERICARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| VIRAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ACETABULUM FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| ALCOHOL POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| ANASTOMOTIC LEAK | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| BRAIN CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| CARTILAGE INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| CLAVICLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| EPICONDYLITIS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| FIBULA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| FRACTURE DISPLACEMENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| HAND FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| JAW FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| JOINT DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| JOINT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| MENISCUS INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| MULTIPLE INJURIES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| POST PROCEDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| SKULL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| SPINAL CORD INJURY CAUDA EQUINA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| TIBIA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| TOXICITY TO VARIOUS AGENTS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| TRAUMATIC INTRACRANIAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| HYPOPROTEINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| IMPAIRED INSULIN SECRETION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| INTERVERTEBRAL DISC DISORDER | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| SYNOVIAL CYST | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| VERTEBRAL OSTEOPHYTE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| BLADDER CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| CHONDROSARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| FIBROADENOMA OF BREAST | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| INTRADUCTAL PROLIFERATIVE BREAST LESION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| OVARIAN GERM CELL TERATOMA BENIGN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| TESTIS CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| THYROID ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| TUMOUR HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| TUMOUR RUPTURE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| UTERINE LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| COGNITIVE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| FACIAL PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| HEAD DISCOMFORT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| LUMBOSACRAL RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| MULTIPLE SCLEROSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| MULTIPLE SCLEROSIS PSEUDO RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| MULTIPLE SCLEROSIS RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| NEUROLOGICAL SYMPTOM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| OPTIC NEURITIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| TRIGEMINAL NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| ABORTION SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | View |
| BREECH PRESENTATION | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| APATHY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| CONVERSION DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| MAJOR DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| STRESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| CALCULUS BLADDER | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| NEPHRITIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| URETHRAL CYST | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| ADENOMYOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| COITAL BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| DYSMENORRHOEA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| ENDOMETRIOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| HEAVY MENSTRUAL BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| MENOMETRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| OVARIAN CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| UTERINE POLYP | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| HYPERSENSITIVITY PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| LARYNGEAL OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| PARANASAL SINUS INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| PULMONARY INFARCTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| TONSILLAR INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| TRACHEAL STENOSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| DRUG ERUPTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| STERILISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| PERIPHERAL VENOUS DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| VARICOSE VEIN | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| MULTIPLE SCLEROSIS RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| INJECTION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |