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| Name | Class |
|---|---|
| Merck, S.L., Spain | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saizen® | Active Comparator |
| |
| Placebo + Saizen® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saizen® | Drug | Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Less Than 11 Tender Points at Month 6 | The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis. | Month 6 |
| Percentage of Participants With Less Than 11 Tender Points at Month 12 | The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) Total Score | Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful). | Baseline, Month 1, 3, 6, 7, 9 and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillem Cuatrecasas, MD | Centro Medico Teknon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Teknon, Endocrinology Department | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22465047 | Derived | Cuatrecasas G, Alegre C, Fernandez-Sola J, Gonzalez MJ, Garcia-Fructuoso F, Poca-Dias V, Nadal A, Cuatrecasas G, Navarro F, Mera A, Lage M, Peino R, Casanueva F, Linan C, Sesmilo G, Coves MJ, Izquierdo JP, Alvarez I, Granados E, Puig-Domingo M. Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia. Pain. 2012 Jul;153(7):1382-1389. doi: 10.1016/j.pain.2012.02.012. Epub 2012 Mar 31. | |
| 20631018 |
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123 subjects were enrolled of whom 113 subjects were randomised and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saizen® | Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9. |
| FG001 | Placebo + Saizen® | Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saizen® | Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Participants With Less Than 11 Tender Points at Month 6 | The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis. | Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Month 6 |
|
Baseline up to Month 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saizen® | Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merck.de |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo and Saizen® | Drug | Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9. |
|
| Visual Analog Scale (VAS) Total Score | Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. | Baseline, Month 1, 3, 6, 7, 9 and 12 |
| EuroQol 5-Dimensions (EQ-5D) Total Score | EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL. | Baseline, Month 1, 3, 6, 7, 9 and 12 |
| Multidimensional Assessment of Fatigue (MAF) Total Score | Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition. | Baseline, Month 6 and 12 |
| Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale | Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate. | Baseline, Month 6 and 12 |
| Derived |
| Cuatrecasas G, Gonzalez MJ, Alegre C, Sesmilo G, Fernandez-Sola J, Casanueva FF, Garcia-Fructuoso F, Poca-Dias V, Izquierdo JP, Puig-Domingo M. High prevalence of growth hormone deficiency in severe fibromyalgia syndromes. J Clin Endocrinol Metab. 2010 Sep;95(9):4331-7. doi: 10.1210/jc.2010-0061. Epub 2010 Jul 14. |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Physician Decision |
|
| Failure to show up at endpoint visits |
|
| BG001 |
| Placebo + Saizen® |
Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo + Saizen® | Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9. |
|
|
| Primary | Percentage of Participants With Less Than 11 Tender Points at Month 12 | The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis. | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Month 12 |
|
|
|
| Secondary | Fibromyalgia Impact Questionnaire (FIQ) Total Score | Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful). | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 1, 3, 6, 7, 9 and 12 |
|
|
|
| Secondary | Visual Analog Scale (VAS) Total Score | Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group. | Posted | Mean | Standard Deviation | mm | Baseline, Month 1, 3, 6, 7, 9 and 12 |
|
|
|
| Secondary | EuroQol 5-Dimensions (EQ-5D) Total Score | EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL. | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 1, 3, 6, 7, 9 and 12 |
|
|
|
| Secondary | Multidimensional Assessment of Fatigue (MAF) Total Score | Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition. | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group. | Posted | Number | Units on a scale | Baseline, Month 6 and 12 |
|
|
|
| Secondary | Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale | Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate. | ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group. | Posted | Number | Percentage of participants | Baseline, Month 6 and 12 |
|
|
|
| 4 |
| 55 |
| 45 |
| 55 |
| EG001 | Placebo + Saizen® | Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9. | 0 | 58 | 51 | 58 |
| Sleep apnoea syndrome | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis media acute | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Aptyalism | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acetonaemic vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain exacerbated | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fall | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Transaminases increased | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Corneal infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injury asphyxiation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Humerus fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pelvic fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Radius fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epicondylitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ganglion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle rupture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wrist deformity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Polyp colorectal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysphemia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Amnesia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sleep talking | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Memory impairment | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertrophy breast | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acute sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Furuncle | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Impaired work ability | Social circumstances | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wheelchair user | Social circumstances | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
| D009422 |
| Nervous System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Month 3 (n=52, 54) |
|
| Month 6 (n=51, 50) |
|
| Month 7 (n=51, 50) |
|
| Month 9 (n=51, 50) |
|
| Month 12 (n=45, 47) |
|
| Month 3 (n=52, 54) |
|
| Month 6 (n=51, 50) |
|
| Month 7 (n=51, 50) |
|
| Month 9 (n=51, 50) |
|
| Month 12 (n=45, 47) |
|
| Month 3 (n=52, 54) |
|
| Month 6 (n=51, 50) |
|
| Month 7 (n=51, 50) |
|
| Month 9 (n=51, 50) |
|
| Month 12 (n=45, 47) |
|
| 1 to 14 questions: Month 12 (n=45, 47) |
|
| 15 and 16 question: Baseline (n=54, 57) |
|
| 15 and 16 question: Month 6 (n=51, 50) |
|
| 15 and 16 question: Month 12 (n=45, 47) |
|
| Month 12 (n=45, 47) |
|