Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01FD004809 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
| University College, London | OTHER |
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Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.
A Phase 2/3, randomized, double-blind, placebo-controlled, international, 20-month intervention study in patients with IBM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arimoclomol | Experimental | 248 mg arimoclomol base (equivalent to 400 mg arimoclomol citrate) 3 times daily |
|
| Placebo | Placebo Comparator | 248 mg matching placebo 3 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arimoclomol | Drug | 2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily during breakfast, early afternoon, and at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. | Change from Baseline to Month 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. | Change from Baseline to Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazen Dimachkie, MD | University of Kansas Medical Center | Principal Investigator |
| Michael Hanna, MD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Neurological Associates | Phoenix | Arizona | 85018 | United States | ||
| University of California, Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38960586 | Derived | Salam S, Symonds T, Doll H, Rousell S, Randall J, Lloyd-Price L, Hudgens S, Guldberg C, Herbelin L, Barohn RJ, Hanna MG, Dimachkie MM, Machado PM; Members of the Arimoclomol in IBM Investigator Team of the Neuromuscular Study Group. Measurement properties of the Inclusion Body Myositis Functional Rating Scale. J Neurol Neurosurg Psychiatry. 2025 Jan 16;96(2):122-131. doi: 10.1136/jnnp-2024-333617. | |
| 37739573 | Derived | Machado PM, McDermott MP, Blaettler T, Sundgreen C, Amato AA, Ciafaloni E, Freimer M, Gibson SB, Jones SM, Levine TD, Lloyd TE, Mozaffar T, Shaibani AI, Wicklund M, Rosholm A, Carstensen TD, Bonefeld K, Jorgensen AN, Phonekeo K, Heim AJ, Herbelin L, Barohn RJ, Hanna MG, Dimachkie MM; Arimoclomol in IBM Investigator Team of the Neuromuscular Study Group. Safety and efficacy of arimoclomol for inclusion body myositis: a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2023 Oct;22(10):900-911. doi: 10.1016/S1474-4422(23)00275-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arimoclomol (20 Months) | Arimoclomol base 248 mg 3 times daily for 20 months |
| FG001 | Placebo (20 Months) | Matching placebo 3 times daily for 20 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat (ITT) population. Patients randomized in error (1 patient in the arimoclomol group and 1 patient in the placebo group) were not included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arimoclomol (20 Months) | Arimoclomol base 248 mg 3 times daily for 20 months |
| BG001 | Placebo (20 Months) | Matching placebo 3 times daily for 20 months |
| 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 | Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. | Intention-to-treat; participants with data at Month 20 | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 20 |
|
From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication.
The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
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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 | Arimoclomol (20 Months) | Arimoclomol base 248 mg 3 times daily for 20 months | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bursitis infective | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | Zevra Denmark A/S | +1-888-289-5607 | medicalaffairs@zevra.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2020 | Feb 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2021 | Feb 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C486387 | arimoclomol |
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| Placebo | Other | 2 matched placebo capsules taken 3 times daily during breakfast, early afternoon, and at bedtime |
|
| Grip Strength | Unilateral hand grip strength in both hands measured using the Jamar Dynamometer. Results are for the stronger limb, as identified at baseline. | Change from Baseline to Month 12 and 20 |
| Modified Timed up and go (mTUG) | The patient's combined ability to rise from a chair and walk 3 meters, turn around and walk back to the chair and sit down. The test was performed twice and the fastest time was used. The results were expressed as velocity in meters/second. | Change from Baseline to Month 12 and Month 20 |
| Manual Muscle Testing (MMT), Total Score | The Manual Muscle Testing (MMT) scores the strength of 24 muscles (axial, proximal, and distal muscles, tested bilaterally) on a scale from 0 to 10 points. The total score is calculated as an average across the 24 muscles and ranges from 0 to 10. The total score will increase if a patient is getting stronger and decrease if a patient is getting weaker. | Change from Baseline to Month 12 and Month 20 |
| 6 Minute Walk Test (6MWT); Distance After 6 Minutes (6MWD) | The distance patients could walk in 6 minutes. The distance walked in meters was recorded after 6 minutes. | Change from Baseline to Month 12 and Month 20 |
| Short Form-36 (SF-36) Physical Component Score | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The physical component score includes 4 scales of physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), and general health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. | Change from Baseline to Month 12 and Month 20 |
| Maximum Voluntary Isometric Contraction (MVICT) of Quadriceps | Unilateral strength of the knee extensor muscles on both limbs using the MicroFET hand-held dynamometer. Results are for the stronger limb, as identified at baseline. | Change from Baseline to Month 12 and Month 20 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | The disability index of the HAQ measures self-reported functional status (disability) including the patient's use of aids or devices and/or help from other persons. The scale is composed of 20 items in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities). Each domain has at least 2 subcategory items, scored on a scale from 0 to 3, and for each of the 8 domains the domain score was the highest score of the involved subcategory scores. The total score reported is an average over 8 domains and scores from at least 6 domains had to be available for the total score to be calculated. The average total score ranges from 0 to 3, and a higher score corresponds to a worsening in functional status. | Change from Baseline to Month 12 and Month 20 |
| 2 Minute Walk Test (2MWT) | The distance patients could walk in 2 minutes (during the 6 Minute Walk Test) recorded in meters. | Change from Baseline to Month 12 and Month 20 |
| Short Form-36 (SF-36) Mental Component Score | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The mental component score is composed of energy/fatigue (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and emotional well-being (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. | Change from Baseline to Month 12 and Month 20 |
| Patient Global Impression of Severity (PGIS) | Patient-reported assessment of the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing) at the time of the assessment. The response options for the impact of IBM were "none" (i.e. no impact), "very mild", "mild", "moderate", "severe", and "very severe". | Change from Baseline to Month 12 and Month 20 |
| Patient Global Impression of Change (PGIC) | Patient-reported assessment of the change from start of study treatment in the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing). The response options for change in impact were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". | Change from Baseline to Month 12 and Month 20 |
| Clinician Global Impression of Severity (CGIS) | Clinician-reported assessment of the severity of the patient's IBM symptoms at the time of the assessment. The response options were "none", "very mild", "mild", "moderate", "severe", and "very severe" | Change from Baseline to Month 12 and Month 20 |
| Clinician Global Impression of Change (CGIC) | Clinician-reported assessment of the change from start of study treatment in the patient's IBM symptoms. The response options for change in IBM were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". | Change from Baseline to Month 12 and Month 20 |
| Falls and Near Falls | Falls and near falls registered by the participants in a diary | Accumulated number from Baseline to Month 20 |
| Irvine |
| California |
| 92697 |
| United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| University College of London | London | WC1N 3BG | United Kingdom |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Age at diagnosis | Mean | Standard Deviation | Years |
|
| Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. | Mean | Standard Deviation | score on a scale |
|
Matching placebo 3 times daily for 20 months
|
|
|
| Secondary | Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. | Intention-to-treat; participants with data at Month 12 | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Month 12 |
|
|
|
| Secondary | Grip Strength | Unilateral hand grip strength in both hands measured using the Jamar Dynamometer. Results are for the stronger limb, as identified at baseline. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | kg | Change from Baseline to Month 12 and 20 |
|
|
|
| Secondary | Modified Timed up and go (mTUG) | The patient's combined ability to rise from a chair and walk 3 meters, turn around and walk back to the chair and sit down. The test was performed twice and the fastest time was used. The results were expressed as velocity in meters/second. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | meters per second (m/sec) | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Manual Muscle Testing (MMT), Total Score | The Manual Muscle Testing (MMT) scores the strength of 24 muscles (axial, proximal, and distal muscles, tested bilaterally) on a scale from 0 to 10 points. The total score is calculated as an average across the 24 muscles and ranges from 0 to 10. The total score will increase if a patient is getting stronger and decrease if a patient is getting weaker. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | 6 Minute Walk Test (6MWT); Distance After 6 Minutes (6MWD) | The distance patients could walk in 6 minutes. The distance walked in meters was recorded after 6 minutes. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | meters | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Short Form-36 (SF-36) Physical Component Score | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The physical component score includes 4 scales of physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), and general health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | score on a scale (physical component) | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Maximum Voluntary Isometric Contraction (MVICT) of Quadriceps | Unilateral strength of the knee extensor muscles on both limbs using the MicroFET hand-held dynamometer. Results are for the stronger limb, as identified at baseline. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | kg | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The disability index of the HAQ measures self-reported functional status (disability) including the patient's use of aids or devices and/or help from other persons. The scale is composed of 20 items in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities). Each domain has at least 2 subcategory items, scored on a scale from 0 to 3, and for each of the 8 domains the domain score was the highest score of the involved subcategory scores. The total score reported is an average over 8 domains and scores from at least 6 domains had to be available for the total score to be calculated. The average total score ranges from 0 to 3, and a higher score corresponds to a worsening in functional status. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | 2 Minute Walk Test (2MWT) | The distance patients could walk in 2 minutes (during the 6 Minute Walk Test) recorded in meters. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | meters | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Short Form-36 (SF-36) Mental Component Score | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The mental component score is composed of energy/fatigue (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and emotional well-being (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Mean | Standard Deviation | score on a scale (mental component) | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Patient Global Impression of Severity (PGIS) | Patient-reported assessment of the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing) at the time of the assessment. The response options for the impact of IBM were "none" (i.e. no impact), "very mild", "mild", "moderate", "severe", and "very severe". | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Count of Participants | Participants | No | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) | Patient-reported assessment of the change from start of study treatment in the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing). The response options for change in impact were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Count of Participants | Participants | No | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Clinician Global Impression of Severity (CGIS) | Clinician-reported assessment of the severity of the patient's IBM symptoms at the time of the assessment. The response options were "none", "very mild", "mild", "moderate", "severe", and "very severe" | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Count of Participants | Participants | No | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Clinician Global Impression of Change (CGIC) | Clinician-reported assessment of the change from start of study treatment in the patient's IBM symptoms. The response options for change in IBM were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". | Intention-to-treat; participants with data at Month 12 and Month 20, respectively | Posted | Count of Participants | Participants | No | Change from Baseline to Month 12 and Month 20 |
|
|
|
| Secondary | Falls and Near Falls | Falls and near falls registered by the participants in a diary | Intention-to-treat | Posted | Mean | Standard Deviation | events (falls or near-falls) per year | Accumulated number from Baseline to Month 20 |
|
|
|
| 73 |
| 11 |
| 73 |
| 72 |
| 73 |
| EG001 | Placebo (20 Months) | Matching placebo 3 times daily for 20 months | 1 | 78 | 18 | 78 | 70 | 78 |
| Cellulitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Chronic hepatitis B | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA Version 20.1 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Alcohol intolerance | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
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Not provided
| D009422 |
| Nervous System Diseases |
| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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| Change from Baseline to Month 20 |
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|
| Mild |
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| Moderate |
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| Severe |
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| Very severe |
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| Month 20 |
|
| A little worse |
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| No change |
|
| A little improved |
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| Much improved |
|
| Very much improved |
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| Missing |
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| Month 20 |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Missing |
|
| Month 20 |
|
| A little worse |
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| No change |
|
| A little improved |
|
| Much improved |
|
| Very much improved |
|
| Missing |
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| Month 20 |
|