Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F1J-JE-HMHB | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 mg Duloxetine | Experimental | Duloxetine 20 milligrams (mg) taken orally once every day for 1 week, followed by 40 mg taken orally once every day for 1 week, and then 60 mg taken orally once every day for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Administered Orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline through 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression-Improvement (PGI-I) at Endpoint | PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). | 50 weeks |
| Clinical Global Impression-Improvement (CGI-I) at Endpoint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miyagi | 982-0032 |
Enrolled participants who completed the 50-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 2-week taper and were observed 1 week post-treatment for safety.
Participants who completed the 15-week treatment in the preceding study F1J-JE-HMGZ (HMGZ) (NCT01552057) were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine 60 mg | Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules). During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline observation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine 60 mg | Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules). During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily. |
| 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 | Number of Participants Who Experienced an Adverse Event (AE) | A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Enrolled participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline through 53 weeks |
|
Baseline through 53 weeks
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 | 60 mg Duloxetine | Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules). During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). |
| 50 weeks |
| Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ) | FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. | Baseline, 50 weeks |
| Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. | Baseline, 50 weeks |
| Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores | The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. | Baseline, 50 weeks |
| Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II) | The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. | Baseline, 50 weeks |
| Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010 | WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. | Baseline, 50 weeks |
| Japan |
| Lost to Follow-up |
|
| Site Removed From Study |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient Global Impression-Improvement (PGI-I) at Endpoint | PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). | Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment. | Posted | Mean | Standard Deviation | units on a scale | 50 weeks |
|
|
|
| Secondary | Clinical Global Impression-Improvement (CGI-I) at Endpoint | CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). | Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment. | Posted | Mean | Standard Deviation | units on a scale | 50 weeks |
|
|
|
| Secondary | Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ) | FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. | Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 50 weeks |
|
|
|
| Secondary | Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. | Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 50 weeks |
|
|
|
| Secondary | Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores | The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. | Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 50 weeks |
|
|
|
| Secondary | Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II) | The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. | Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 50 weeks |
|
|
|
| Secondary | Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010 | WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. | Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 50 weeks |
|
|
|
| 8 |
| 149 |
| 138 |
| 149 |
| Subileus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Self injurious behaviour | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blepharitis allergic | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Corneal degeneration | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Scleral haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Submandibular mass | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myofascitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Autonomic neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Radial nerve palsy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somatoform disorder gastrointestinal | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| D009422 |
| Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Pain Right Now |
|
| Interference With General Activity |
|
| Interference With Mood |
|
| Interference With Walking Ability |
|
| Interference With Normal Work |
|
| Interference With Relations With Other People |
|
| Interference With Sleep |
|
| Interference With Enjoyment of Life |
|
| Average Interference |
|
| Title | Measurements |
|---|---|
|
| General Health |
|
| Vitality |
|
| Social Functioning |
|
| Role-Emotional |
|
| Mental Health |
|