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 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
NCT ID:
NCT00451451
Description:
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT00451451
Study Brief:
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received two placebo capsules orally three times daily (TID) | None | None | 79 | 363 | 332 | 363 | View |
| BG00012 240 mg Twice Daily (BID) | Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) | None | None | 61 | 359 | 336 | 359 | View |
| BG00012 240 mg 3 Times Daily (TID) | Participants received two 120 mg BG00012 capsules orally three times daily (TID) | None | None | 54 | 344 | 316 | 344 | View |
| Total BG00012 | Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group | None | None | 115 | 703 | 652 | 703 | View |
| Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD) | None | None | 60 | 351 | 303 | 351 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| DOUGLAS' ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| H1N1 INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| PELVIC INFLAMMATORY DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| BORRELIA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| ENDOCARDITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| PYOTHORAX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| TRACHEITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| UTERINE LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| BREAST NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| CERVIX CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| ENDOMETRIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| FIBROMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| THYROID CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.1) | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.1) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.1) | View |
| DIABETIC KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.1) | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| MULTIPLE SCLEROSIS RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| BENIGN INTRACRANIAL HYPERTENSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| GRAND MAL CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| OCCIPITAL NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| PARTIAL SEIZURES | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| RESTLESS LEGS SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| CEREBROVASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| LOSS OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| MULTIPLE SCLEROSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.1) | View |
| HOLMES-ADIE PUPIL | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.1) | View |
| VISUAL ACUITY REDUCED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.1) | View |
| VESTIBULAR ATAXIA | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.1) | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| MYOCARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| DIVERTICULAR PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| DUODENITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| PANCREATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| BILE DUCT STONE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| BURSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| SPINAL OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| BLADDER DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| BLADDER PERFORATION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| ABORTION SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | View |
| GESTATIONAL OEDEMA | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | View |
| MENORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.1) | View |
| METRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.1) | View |
| BARTHOLIN'S CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.1) | View |
| UTERINE HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.1) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| MUSCLE STRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| ALCOHOL POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| FACIAL BONES FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| LIGAMENT RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| TRAUMATIC HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| WRIST FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| EYE INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| HAND FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| LIGAMENT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| MENISCUS LESION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| WHIPLASH INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| BREAST LUMP REMOVAL | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| INTERVERTEBRAL DISC OPERATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| MEDICAL DIET | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| CERVICAL CONISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| STERILISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| TURBINECTOMY | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| SOCIAL PROBLEM | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (13.1) | View |
| BIPOLAR I DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| NASAL POLYPS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.1) | View |
| BLADDER DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| NEPHROPTOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| HERNIA OBSTRUCTIVE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| BETA 2 MICROGLOBULIN URINE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| THERAPEUTIC AGENT TOXICITY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| MULTIPLE SCLEROSIS RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.1) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| MICROALBUMINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| ALBUMIN URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| PROTEIN URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.1) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.1) | View |
| PRURITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.1) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.1) | View |