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 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
NCT ID:
NCT00552305
Description:
None
Frequency Threshold:
5
Time Frame:
The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
Study:
NCT00552305
Study Brief:
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lacosamide | 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing) | None | None | 125 | 370 | 307 | 370 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| SINUS BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| ANGINA PECTORIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| ACUTE CORONARY SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| CARDIAC FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| CARDIOMYOPATHY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| CORONARY ARTERY STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| CORONARY ARTERY DISEASE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| VISION BLURRED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| INGUINAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| HAEMORRHOIDS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| IRRITABLE BOWEL SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| RECTAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| COLONIC POLYP | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| ILEUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| ENTEROCELE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| IRRITABILITY | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| CHOLELITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (9.1) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| APPENDICITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| BACTERIAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| GASTROINTESTINAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| HAND FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| DRUG TOXICITY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| ANKLE FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| HEAD INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| INTENTIONAL OVERDOSE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| CEREBRAL HAEMORRHAGE TRAUMATIC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| PELVIC FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| POST-TRAUMATIC PAIN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| TREATMENT NONCOMPLIANCE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| CERVICAL VERTEBRAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| LOWER LIMB FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| OVERDOSE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| PNEUMOTHORAX TRAUMATIC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| RIB FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| ROAD TRAFFIC ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| THORACIC VERTEBRAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| TIBIA FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| HIP FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| MEDICAL DEVICE COMPLICATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| SPINAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| THERMAL BURN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| JOINT INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| THERAPEUTIC AGENT TOXICITY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| ELECTROENCEPHALOGRAM | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| ELECTROCARDIOGRAM QRS COMPLEX PROLONGED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| BIOPSY | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| INVESTIGATION | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| ELECTROCARDIOGRAM CHANGE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| HEART RATE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| URINARY CASTS | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| HYPOCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| FLANK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| OSTEOARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| MUSCULAR WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| ARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| SPINAL COLUMN STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| LUMBAR SPINAL STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| CHRONIC LYMPHOCYTIC LEUKAEMIA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| HEPATIC NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| HAEMANGIOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| SQUAMOUS CELL CARCINOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| GLIOBLASTOMA MULTIFORME | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| THYROID NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| BREAST CANCER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| OVARIAN CANCER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| COLON NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| STATUS EPILEPTICUS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| TRANSIENT ISCHAEMIC ATTACK | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| HEMIPARESIS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| GRAND MAL CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| CEREBRAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| EPILEPSY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| ENCEPHALOPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| CEREBRAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| METABOLIC ENCEPHALOPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| MYASTHENIA GRAVIS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| MYASTHENIA GRAVIS CRISIS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| COGNITIVE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| CEREBROVASCULAR ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| COORDINATION ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| BALANCE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| PSYCHOMOTOR HYPERACTIVITY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| OPTIC NEURITIS RETROBULBAR | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| COMPLEX PARTIAL SEIZURES | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| PREGNANCY | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | View |
| CONFUSIONAL STATE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| MAJOR DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| AGGRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| SUICIDAL IDEATION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| EPILEPTIC PSYCHOSIS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| HALLUCINATION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| PARANOIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| SUICIDE ATTEMPT | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| ACUTE PSYCHOSIS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| HALLUCINATION, AUDITORY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| NIGHTMARE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| NEPHROLITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| RENAL FAILURE ACUTE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| PROTEINURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| DYSFUNCTIONAL UTERINE BLEEDING | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| UTERINE HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| PULMONARY FIBROSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| ASPHYXIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| ASTHMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| PNEUMOTHORAX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| ACUTE RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| ABORTION INDUCED | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| THERAPY REGIMEN CHANGED | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| BRAIN OPERATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| HYSTERECTOMY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| SURGERY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| BRAIN LOBECTOMY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| STENT PLACEMENT | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| VAGAL NERVE STIMULATOR REMOVAL | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| NASAL SEPTAL OPERATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| CIRCULATORY COLLAPSE | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| VERTIGO | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.1) | View |
| UPPER LIMB FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| ELECTROCARDIOGRAM ST SEGMENT ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| HYPERCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| INTERVERTEBRAL DISC PROTRUSION | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIPLOPIA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| VISION BLURRED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| CONTUSION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| SKIN LACERATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| EXCORIATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| JOINT SPRAIN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| MUSCULAR WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| COORDINATION ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| SOMNOLENCE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| TREMOR | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| MEMORY IMPAIRMENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| BALANCE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| NYSTAGMUS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| HYPOAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| PHARYNGOLARYNGEAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |