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This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
Hemophilia A is a condition in which blood is unable to clot effectively. It is caused by a mutation or deletion in the gene that is responsible for producing blood-clotting factor VIII protein. Individuals with hemophilia A suffer from repeated bleeding episodes, often into the joints, which can cause chronic joint disease and sometime results in death due to the inability of the blood to clot efficiently. This chronic joint disease can have significant physical, psychosocial, and quality-of-life effects, including financial burden. The current standard of care includes the use of factor-based therapies which are given either as prophylaxis or to treat bleeding, as well as new non-factor prophylaxis therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPK-8011 5x10^11 vg/kg | Experimental | Participants received a single intravenous (IV) infusion of SPK-8011 5x10^11 vector genomes per kilogram (vg/kg) body weight. |
|
| SPK-8011 1x10^12 vg/kg | Experimental | Participants received a single IV infusion of SPK-8011 1x10^12 vg/kg. |
|
| SPK-8011 2x10^12 vg/kg | Experimental | Participants received a single IV infusion of SPK-8011 2x10^12 vg/kg. |
|
| SPK-8011 1.5x10^12 vg/kg | Experimental | Participants received a single IV infusion of SPK-8011 1.5x10^12 vg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPK-8011 | Genetic | A novel, bio-engineered, recombinant adeno-associated viral vector carrying human factor VIII gene |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as adverse events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, are a congenital anomaly or birth defect, or are an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE is defined as an AE with an onset date on or following SPK-8011 administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | From date of first dose to Week 52/End of Study (EOS) Visit |
| Number of Participants Who Received Corticosteroids for Presumed Immune Response | Up to Week 52/EOS Visit | |
| Peak Factor VIII (FVIII) Activity Levels Assessed by One-Stage Coagulation Assay (OSA) | Median peak FVIII activity up to Week 52 | Up to Week 52/EOS visit |
| Nominal FVIII Level by OSA at Week 52/EOS | Steady-state FVIII activity measured by median FVIII levels at week 52 by OSA. | Up to Week 52/EOS Visit |
| Spontaneous Bleeds Annualized Bleeding Rate | Week 5 up to Week 52/EOS Visit | |
| Total Annualized FVIII Infusion Rate | Week 5 up to Week 52/EOS Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Peak FVIII Activity Level | Up to Week 52/EOS Visit | |
| Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids | Up to Week 52/EOS Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Director | Spark Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis - Hemostasis and Thrombosis Center | Sacramento | California | 94817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34788507 | Derived | George LA, Monahan PE, Eyster ME, Sullivan SK, Ragni MV, Croteau SE, Rasko JEJ, Recht M, Samelson-Jones BJ, MacDougall A, Jaworski K, Noble R, Curran M, Kuranda K, Mingozzi F, Chang T, Reape KZ, Anguela XM, High KA. Multiyear Factor VIII Expression after AAV Gene Transfer for Hemophilia A. N Engl J Med. 2021 Nov 18;385(21):1961-1973. doi: 10.1056/NEJMoa2104205. | |
| 32258217 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPK-8011 5x10^11 vg/kg | Participants received a single intravenous infusion of SPK-8011 5x10^11 vector genomes per kilogram body weight (vg/kg). |
| FG001 | SPK-8011 1x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1x10^12 vg/kg. |
| FG002 | SPK-8011 2x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 2x10^12 vg/kg. |
| FG003 | SPK-8011 1.5x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1.5x10^12 vg/kg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Full Analysis Set included all participants who received the infusion of SPK-8011.
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| ID | Title | Description |
|---|---|---|
| BG000 | SPK-8011 5x10^11 vg/kg | Participants received a single intravenous infusion of SPK-8011 5x10^11 vg/kg. |
| BG001 | SPK-8011 1x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1x10^12 vg/kg. |
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as adverse events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, are a congenital anomaly or birth defect, or are an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE is defined as an AE with an onset date on or following SPK-8011 administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Count of Participants | Participants | From date of first dose to Week 52/End of Study (EOS) Visit |
|
From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
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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 | SPK-8011 5x10^11 vg/kg | Participants received a single intravenous infusion of SPK-8011 5x10^11 vg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Spark Therapeutics | Spark Therapeutics | Please Email | clinicaltrials@sparktx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2021 | Dec 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2024 | Dec 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D001778 | Blood Coagulation Disorders |
| D025861 | Blood Coagulation Disorders, Inherited |
| D020147 | Coagulation Protein Disorders |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Incidence of Immune Response to the BDD-hFVIII Transgene | Up to Week 52/EOS Visit |
| University of Florida Health |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | United States |
| Weill Cornell Medicine-Comprehensive Center for Hemophilia and Coagulation Disorders | New York | New York | 10065 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Pennsylvania State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | 10733 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson University Hospitals | Philadelphia | Pennsylvania | 19107 | United States |
| Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213 | United States |
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 23219 | United States |
| Royal Prince Alfred Hosptial | Camperdown | New South Wales | 2050 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| McMaster University Medical Centre and Juravinski Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| Chaim Sheba Center | Ramat Gan | Tel Hashomer | 526000 | Israel |
| Mahidol University - Ramathibody Hospital | Bangkok | 10400 | Thailand |
| Ran G, Chen X, Xie Y, Zheng Q, Xie J, Yu C, Pittman N, Qi S, Yu FX, Agbandje-McKenna M, Srivastava A, Ling C. Site-Directed Mutagenesis Improves the Transduction Efficiency of Capsid Library-Derived Recombinant AAV Vectors. Mol Ther Methods Clin Dev. 2020 Mar 13;17:545-555. doi: 10.1016/j.omtm.2020.03.007. eCollection 2020 Jun 12. |
| BG002 | SPK-8011 2x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 2x10^12 vg/kg. |
| BG003 | SPK-8011 1.5x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1.5x10^12 vg/kg. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| SPK-8011 5x10^11 vg/kg |
Participants received a single intravenous infusion of SPK-8011 5x10^11 vg/kg. |
| OG001 | SPK-8011 1x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1x10^12 vg/kg. |
| OG002 | SPK-8011 2x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 2x10^12 vg/kg. |
| OG003 | SPK-8011 1.5x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1.5x10^12 vg/kg. |
|
|
| Primary | Number of Participants Who Received Corticosteroids for Presumed Immune Response | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Count of Participants | Participants | Up to Week 52/EOS Visit |
|
|
|
| Primary | Peak Factor VIII (FVIII) Activity Levels Assessed by One-Stage Coagulation Assay (OSA) | Median peak FVIII activity up to Week 52 | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Median | Full Range | percentage of normal activity | Up to Week 52/EOS visit |
|
|
|
| Primary | Nominal FVIII Level by OSA at Week 52/EOS | Steady-state FVIII activity measured by median FVIII levels at week 52 by OSA. | The Full Analysis Set included all participants who received the infusion of SPK-8011. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure. | Posted | Median | Full Range | percentage of normal activity | Up to Week 52/EOS Visit |
|
|
|
| Primary | Spontaneous Bleeds Annualized Bleeding Rate | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Median | Inter-Quartile Range | annualized number of bleeding events | Week 5 up to Week 52/EOS Visit |
|
|
|
| Primary | Total Annualized FVIII Infusion Rate | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Mean | Standard Deviation | total annualized FVIII infusions | Week 5 up to Week 52/EOS Visit |
|
|
|
| Secondary | Time to Achieve Peak FVIII Activity Level | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Mean | Standard Deviation | days | Up to Week 52/EOS Visit |
|
|
|
| Secondary | Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Count of Participants | Participants | Up to Week 52/EOS Visit |
|
|
|
| Secondary | Incidence of Immune Response to the BDD-hFVIII Transgene | The Full Analysis Set included all participants who received the infusion of SPK-8011. | Posted | Count of Participants | Participants | Up to Week 52/EOS Visit |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | SPK-8011 1x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1x10^12 vg/kg. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | SPK-8011 2x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 2x10^12 vg/kg. | 0 | 9 | 1 | 9 | 9 | 9 |
| EG003 | SPK-8011 1.5x10^12 vg/kg | Participants received a single intravenous infusion of SPK-8011 1.5x10^12 vg/kg. | 0 | 11 | 3 | 11 | 11 | 11 |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Adrenal Insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Scleral Hyperaemia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gingival Discolouration | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal Mass | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Salivary Gland Mass | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Feeling Jittery | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Generalised Oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperplastic Cholecystopathy | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Allergy To Arthropod Sting | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis Infected | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Herpes Dermatitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nail Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Otitis Media Acute | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pulpitis Dental | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Chemical Burn | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Glycosylated Haemoglobin Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Sars-Cov-2 Test Positive | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seronegative Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Morton's Neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Attention Deficit Hyperactivity Disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal Cyst | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Testicular Disorder | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngeal Swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ingrowing Nail | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Saliva |
|
| Semen |
|
| Serum |
|
| Urine |
|