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Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).
This is an open-label study aimed to assess long-term safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Up to 500 adult patients with a confirmed clinical diagnosis of CD are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study, patients will receive repeat injections of MYOBLOC every 12 weeks when deemed appropriate by the Investigator. Injections should not occur more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Treatment | Experimental | 5,000 units up to 25,000 units of MYOBLOC (Botulinum Toxin Type B) injections every 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type B | Biological | Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms | 7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms | Session 1 - Time 0, 4 weeks post-injection compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 2 (12 wks) - 4 weeks post-injection compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan T Rubin, MD | Supernus Pharmaceuticals, Inc. | Study Director |
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Subjects had to be Botulinum Toxin Type B naive and could not have received a Botulinum Toxin Type A treatment within 12 weeks of enrollment.
Approximately 500 subjects were recruited from 36 centers in North America.
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| ID | Title | Description |
|---|---|---|
| FG000 | MYOBLOC Open Label Treatment | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MYOBLOC Treatment Session 1 (Time 0) |
| |||||||||||||
| MYOBLOC Treatment Session 2 (App 12 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 3 (App 24 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 4 (App 36 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 5 (App 48 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 6 (App 60 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 7 (App 72 Wks) |
| |||||||||||||
| MYOBLOC Treatment Session 8 (App 84 Wks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MYOBLOC Open Label Treatment | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms | 7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms | Safety Population/Intent to Treat | Posted | Mean | Standard Error | points on a scale | Session 1 - Time 0, 4 weeks post-injection compared to baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MYOBLOC Open Label Treatment | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Supernus Pharmaceuticals, Inc. | clinicaltrials@supernus.com |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C096323 | rimabotulinumtoxinB |
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|
| Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 3 (24 Wks) - 4 weeks post-injection compared to baseline |
| Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 4 (36 Wks) - 4 weeks post-injection compared to baseline |
| Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 5 (48 Wks) - 4 weeks post-injection compared to baseline |
| Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 6 (60 Wks) - 4 weeks post-injection compared to baseline |
| Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 7 (72 Wks) - 4 weeks post-injection compared to baseline |
| Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | safety population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 2 (12 wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | safety population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 3 (24 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | safety population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 4 (36 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Safety Population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 5 (48 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Safety Population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 6 (60 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Safety Population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 7 (72 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms | Safety Population/Intent to Treat | Posted | Mean | Standard Deviation | points on a scale | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline |
|
|
|
| 133 |
| 494 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| AV Block 2nd Degree | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary Artery Occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
|
| eye haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| abdominal adhesions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| appendicitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| celiac disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| diverticulum | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GI hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GI Reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| inguinal hernia obsstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| small intestine obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| upper GI hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| chest pain | General disorders | MedDRA | Systematic Assessment |
|
| facial pain | General disorders | MedDRA | Systematic Assessment |
|
| non cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| pain | General disorders | MedDRA | Systematic Assessment |
|
| bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| hepatorenal syndrome | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| arthritis infective | Infections and infestations | MedDRA | Systematic Assessment |
|
| bartholin abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| GI norwalk virus | Infections and infestations | MedDRA | Systematic Assessment |
|
| GI viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| haemophilis infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| pelvic abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| post operative abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Infection (URI) | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Infections and infestations | MedDRA | Systematic Assessment |
|
| vaginal cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| brain contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| drug toxicitiy | Infections and infestations | MedDRA | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| medication error | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| multiple fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| post procedural nausea | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| post pocedural vomiting | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| post operative ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| subdural hematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| oxygen saturation decrease | Investigations | MedDRA | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| back disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| intervebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| intervebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| benign ovarian tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| bone neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| keratocanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebrovascular Accident (CVA) | Nervous system disorders | MedDRA | Systematic Assessment |
|
| cervical myelopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| dystonia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| intracranial aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
|
| mutiple sclerosis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
|
| pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| dissociative identity disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| bladder prolapse | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| stress incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| cystocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| endometriosis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| menorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| ovarian cyst rupture | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| pelvic peritoneal adhesions | Reproductive system and breast disorders | MdDRA | Systematic Assessment |
|
| rectocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| atelectasis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| choking | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MEdDRA | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| blood pressure fluctuation | Vascular disorders | MedDRA | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| haemotoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MeddRA | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | MdDRA | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| asthenia | General disorders | MedDRA | Systematic Assessment |
|
| chest pain | General disorders | MedDRA | Systematic Assessment |
|
| fatigue | General disorders | MedDRA | Systematic Assessment |
|
| influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| injection site reaction | General disorders | MedDRA | Systematic Assessment |
|
| edema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| GI viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| joint sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| muscle sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
|
| hypercholesterolemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| interverterbral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| musculoskeletal weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| head titubation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| stress | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| choking | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| pharangolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
No individual PI can disclose results until after a group manuscript is published.
| D013568 |
| Pathological Conditions, Signs and Symptoms |