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This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A 900kD | Active Comparator | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
|
| Placebo | Placebo Comparator | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A 900kD | Biological | The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 | Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | Canada | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21174051 | Derived | Borg J, Ward AB, Wissel J, Kulkarni J, Sakel M, Ertzgaard P, Akerlund P, Reuter I, Herrmann C, Satkunam L, Wein T, Girod I, Wright N; BEST Study Group. Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity. J Rehabil Med. 2011 Jan;43(1):15-22. doi: 10.2340/16501977-0663. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A 900kD | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| FG001 | Placebo | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A 900kD | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 | Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 24 |
|
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The Safety Population included all patients who were randomized and received at least 1 injection
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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 | Botulinum Toxin Type A 900kD | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Megaloblastic | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Placebo | Biological | The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
|
| Week 12 |
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected | Week 52 |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Week 12 |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Week 24 |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Week 52 |
| Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Baseline, Week 12 |
| Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Baseline, Week 24 |
| Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Baseline, Week 52 |
| Direct Costs for Canada | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada. | 52 Weeks |
| Direct Costs for Germany | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany. | 52 Weeks |
| Direct Costs for Sweden | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden. | 52 Weeks |
| Direct Costs for the United Kingdom | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom. | 52 Weeks |
| Beelitz |
| Germany |
| Uppsala | Sweden |
| Burslem | Stoke-on-Trent | United Kingdom |
First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. |
|
|
| Secondary | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| Secondary | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 52 |
|
|
|
| Secondary | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| Secondary | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 24 |
|
|
|
| Secondary | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Number | Percentage of Patients | Week 52 |
|
|
|
| Secondary | Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12 |
|
|
|
| Secondary | Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. | Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 52 |
|
|
|
| Secondary | Direct Costs for Canada | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada. | Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Canadian dollar (CAD) | 52 Weeks |
|
|
|
| Secondary | Direct Costs for Germany | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany. | Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Euro (EUR) | 52 Weeks |
|
|
|
| Secondary | Direct Costs for Sweden | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden. | Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | Swedish Krona (SEK) | 52 Weeks |
|
|
|
| Secondary | Direct Costs for the United Kingdom | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom. | Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection. | Posted | Mean | Standard Deviation | British Pound (GBP) | 52 Weeks |
|
|
|
| 47 |
| 139 |
| 60 |
| 139 |
| EG001 | Placebo | First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. | 45 | 134 | 45 | 134 |
| Angina Pectoris | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Left Ventricular Failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Adverse Drug Reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Non-cardiac Chest Pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Escherichia Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Depressed Level of Consciousness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lacunar Infarction | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle Spasticity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Partial Seizures | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Circulatory Collapse | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Temporal Arteritis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Not provided
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |