Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 01-9004 | Other Identifier | Teva |
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This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glatiramer Acetate: Delayed Start | Experimental | Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months. |
|
| Glatiramer Acetate: Early Start | Experimental | Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer acetate | Drug | Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section. | Baseline up to Month 288 |
| Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 | The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis). | Baseline, Month 288 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cory Ford, MD | University of New Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 009 | Los Angeles | California | 90033 | United States | ||
| Teva Investigational Site 004 |
A total of 209 participants were screened; 208 participants met entry criteria and were enrolled in this study.
Participants who participated in both or either Studies 01-9001 (double-blind [DB] placebo-controlled study) and 01-9001E (DB extension study) were eligible to enter into this open-label extension study. Note that the 01-9001 and 01-9001E studies predate NCT assignments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glatiramer Acetate: Delayed Start | Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 |
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|
| Los Angeles |
| California |
| 90095-7077 |
| United States |
| Teva Investigational Site 008 | New Haven | Connecticut | 06520-8018 | United States |
| Teva Investigational Site 005 | Baltimore | Maryland | 21201 | United States |
| Teva Investigational Site 003 | Detroit | Michigan | 48201 | United States |
| Teva Investigational Site 002 | Albuquerque | New Mexico | 87131 | United States |
| Teva Investigational Site 007 | Rochester | New York | 14642 | United States |
| Teva Investigational Site 001 | Philadelphia | Pennsylvania | 19104 | United States |
| Teva Investigational Site 010 | Houston | Texas | 77030 | United States |
| Teva Investigational Site 006 | Salt Lake City | Utah | 84148 | United States |
| Teva Investigational Site 011 | Madison | Wisconsin | 53719 | United States |
| FG001 | Glatiramer Acetate: Early Start | Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glatiramer Acetate: Delayed Start | Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. |
| BG001 | Glatiramer Acetate: Early Start | Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section. | 01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study. | Posted | Number | participants | Baseline up to Month 288 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 | The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis). | 01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 288 |
|
Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
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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 | Glatiramer Acetate: Delayed Start | Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. | 4 | 107 | 44 | 107 | 107 | 107 |
| EG001 | Glatiramer Acetate: Early Start | Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. | 1 | 101 | 38 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Diverticulitis Meckel's | Congenital, familial and genetic disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Adhesion | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Haemorrhagic cyst | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Catheter site abscess | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Wound infection fungal | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Gastrointestinal injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Cardiac output decreased | Investigations | MedDRA v19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Drug withdrawal convulsions | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Bladder repair | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Femoral hernia repair | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Hysterosalpingo-oophorectomy | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Small intestinal resection | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Spinal laminectomy | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v19.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| Jun 24, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| American Indian or Alaskan Native |
|
| Other |
|
| Missing |
|
|
|