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| Name | Class |
|---|---|
| CMIC Co, Ltd. Japan | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
| Quintiles Malaysia Sdn Bhd | INDUSTRY |
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Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo
[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.
[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo group (14 weeks) |
|
| DS-5565 15mg | Experimental | DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose |
|
| DS-5565 20 mg group | Experimental | DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose |
|
| DS-5565 30 mg group | Experimental | DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5565 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. | Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg]) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saiki Central Hospital | Ōita | 876-0851 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059327 | Derived | Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (~750 target cases). LT phase confirm long-term safety (~180 target cases).
A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants who received an oral dose of placebo twice daily (BID) for 14 weeks. |
| FG001 | DS-5565 15mg QD | Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks. |
| FG002 | DS-5565 20 mg (10 mg BID) | Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks. |
| FG003 | DS-5565 30 mg (15 mg BID) | Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks. |
| FG004 | DS-5565 Open-label Extension | Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
| ||||||||||||||||||
| Open-label Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants who received an oral dose of placebo twice daily (BID) for 14 weeks. |
| BG001 | DS-5565 15mg QD | Participants who received an oral dose of DS-5565 15 mg QD. During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. | ADPS was assessed in the Modified-Intent-to-Treat Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg]) |
|
Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months.
A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
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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 | Placebo | Participants who received an oral dose of placebo twice daily (BID) for 14 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo, Inc. | 1-908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2016 | Aug 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
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| placebo |
| Drug |
|
| From baseline (Week 14) to Week 66 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| Death |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | DS-5565 20 mg (10 mg BID) | Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks. |
| BG003 | DS-5565 30 mg (15 mg BID) | Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Placebo | Participants who received an oral dose of placebo twice daily (BID) for 14 weeks. |
| OG001 | DS-5565 15mg QD | Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks. |
| OG002 | DS-5565 20 mg (10 mg BID) | Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks. |
| OG003 | DS-5565 30 mg (15 mg BID) | Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks. |
|
|
|
| Secondary | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. | Visual analog scale was assessed in all enrolled participants. | Posted | Mean | Standard Deviation | units on a scale | From baseline (Week 14) to Week 66 |
|
|
|
| 0 |
| 330 |
| 11 |
| 330 |
| 101 |
| 330 |
| EG001 | DS-5565 15mg QD | Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks. | 0 | 164 | 4 | 164 | 60 | 164 |
| EG002 | DS-5565 20 mg (10 mg BID) | Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks. | 2 | 165 | 8 | 165 | 62 | 165 |
| EG003 | DS-5565 30 mg (15 mg BID) | Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks. | 0 | 165 | 11 | 165 | 84 | 165 |
| EG004 | DS-5565 Open-label Extension | Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings. | 1 | 214 | 24 | 214 | 141 | 214 |
| Perinephric abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cerebal infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral arterial occlusion | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Ulnar nerve injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Week 26 |
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| Week 30 |
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| Week 34 |
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| Week 38 |
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| Week 42 |
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| Week 46 |
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| Week 50 |
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| Week 54 |
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| Week 58 |
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| Week 62 |
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| Week 66 |
|