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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006488-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Eisai Limited | INDUSTRY |
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The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Perampanel 2mg | Active Comparator |
| |
| Perampanel 4mg | Active Comparator |
| |
| Perampanel 6mg | Active Comparator |
| |
| Perampanel 8mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablets, once daily, for 15 weeks (taken orally). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF). | Baseline to Week 15/EOT |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. | Baseline to Week 15/EOT |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. | Baseline to Week 15/EOT |
| Mean Change in Average Pain Scores From Baseline at Each Study Week | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug. | Baseline, Week 1 to Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF. | Baseline to Week 15/EOT |
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INCLUSION CRITERIA:
To be included, patients must meet all of the following:
Provide written informed consent, prior to entering the study or undergoing any study procedures
Male and female patients ≥18 years of age will be eligible for enrollment. Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least 1 month before Screening (Visit 1) and for 1 month after the end of the study (Visit 8). They must also have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening (Visit 1). Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) starting with the Baseline Phase and continuing throughout the study period.
Have Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
Have pain that has been stable over the past 6 months and, in the opinion of the investigator, not in an identifiably improving or worsening trend
Have hemoglobin A1c ≤ 11%
Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Screening (Visit 1) and Baseline (Visit 2 prior to randomization)
Have completed the patient diary for at least 6 of the 7 days prior to Baseline (Visit 2)
Have average daily pain score of ≥ 4, on 11-point Likert-type numeric rating scale during the 7 days prior to Baseline (to be obtained from the patient diary)
Be reliable, willing, and able to cooperate with all study procedures including the following:
Be on stable antidiabetic treatment (insulin, oral agents, or lifestyle) that is not anticipated to change during the course of the study, except if medically required
Be on stable analgesic treatment (same medication and dose) or stable nonpharmacological pain treatment for at least 4 weeks prior to Screening (Visit 1) and remain on this stable treatment throughout the study (unless otherwise directed by a physician). Nonpharmacologic pain treatment includes the following: relaxation/hypnosis, physical or occupational therapy, counseling, etc. Episodic or periodic treatments such as monthly injections for treatment of pain (e.g., local anesthetics) will not be permitted.
EXCLUSION CRITERIA:
Patients with any one of the following will be excluded.
Patients with any condition that could interfere with the conduct of the study or confound efficacy evaluations including the following:
Patients motivated by secondary gain, or where there is a negative-incentive to achieving pain and functional pain relief (eg, litigation). This will be determined by the patient's medical history.
Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine (other than diabetes), or immunologic, including patients with any of the following broad disease categories:
Patients with any of the following laboratory abnormalities at Screening (Visit 1) or Baseline (Visit 2):
Exposure to an investigational drug (including E2007) within the 30 days prior to Screening (Visit 1) or any prior exposure to E2007.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Laurenza, M.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Richard Blonsky | Chicago | Illinois | 60610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | Perampanel 2mg | (Perampanel 2mg once daily for 15 weeks) |
| FG002 | Perampanel 4mg | (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks) |
| FG003 | Perampanel 6mg | (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks) |
| FG004 | Perampanel 8mg | (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | Perampanel 2mg | (Perampanel 2mg once daily for 15 weeks) |
| BG002 | Perampanel 4mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF). | Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline to Week 15/EOT |
|
Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 10.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 10.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
Not provided
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| E2007 (2 mg) |
| Drug |
Perampanel, 2 mg once daily, for 15 weeks (taken orally). |
|
|
| E2007 (4 mg) | Drug | Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally). |
|
|
| E2007 (6 mg) | Drug | Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally). |
|
|
| E2007 (8 mg) | Drug | Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally). |
|
|
| Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity. | Baseline and Week 15/EOT |
| Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF. | Week 15/EOT |
| Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status. | Baseline and Week 15/EOT |
| Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21. | Baseline and Week 15/EOT |
| Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure. | Baseline and Week 15 |
| Presence or Absence of Allodynia at Week 15/EOT | Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed. | Week 15/EOT |
| Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication. | Baseline to Week 15 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Other |
|
(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks) |
| BG003 | Perampanel 6mg | (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks) |
| BG004 | Perampanel 8mg | (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Baseline characteristics look at Safety Population (subjects who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline assessment). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | This baseline characteristic is for Race. | Number | participants |
|
| OG002 |
| Perampanel 4mg |
(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks) |
| OG003 | Perampanel 6mg | (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks) |
| OG004 | Perampanel 8mg | (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks) |
|
|
| Primary | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. | ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT. | Posted | Number | Percentage of Participants | Baseline to Week 15/EOT |
|
|
|
| Primary | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. | ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT. | Posted | Number | Percentage of Participants | Baseline to Week 15/EOT |
|
|
|
| Primary | Mean Change in Average Pain Scores From Baseline at Each Study Week | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 1 to Week 17 |
|
|
|
| Secondary | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline to Week 15/EOT |
|
|
|
| Secondary | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 15/EOT |
|
|
|
| Secondary | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF. | Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit. | Posted | Number | Participants | Week 15/EOT |
|
|
|
| Secondary | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 15/EOT |
|
|
|
| Secondary | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 15/EOT |
|
|
|
| Secondary | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure. | ITT Population | Posted | Number | Participants | Baseline and Week 15 |
|
|
|
| Secondary | Presence or Absence of Allodynia at Week 15/EOT | Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed. | ITT Population | Posted | Number | Participants | Week 15/EOT |
|
|
|
| Secondary | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication. | ITT Population | Posted | Number | Participants | Baseline to Week 15 |
|
|
|
| 2 |
| 71 |
| 26 |
| 71 |
| EG001 | Perampanel 2mg | (Perampanel 2mg once daily for 15 weeks) | 2 | 71 | 30 | 71 |
| EG002 | Perampanel 4mg | (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks) | 2 | 68 | 33 | 68 |
| EG003 | Perampanel 6mg | (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks) | 8 | 67 | 40 | 67 |
| EG004 | Perampanel 8mg | (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks) | 8 | 68 | 38 | 68 |
| Atrial Fibrillation | Cardiac disorders | MedDRA v. 10.1 |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA v. 10.1 |
|
| Tachycardia | Cardiac disorders | MedDRA v. 10.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v. 10.1 |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA v. 10.1 |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA v. 10.1 |
|
| Multi-organ Failure | General disorders | MedDRA v. 10.1 |
|
| Death | General disorders | MedDRA v. 10.1 |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v. 10.1 |
|
| Sepsis | Infections and infestations | MedDRA v. 10.1 |
|
| Cellulitis | Infections and infestations | MedDRA v. 10.1 |
|
| Cystitis | Infections and infestations | MedDRA v. 10.1 |
|
| Escherichia Infection | Infections and infestations | MedDRA v. 10.1 |
|
| Labyrinthitis | Infections and infestations | MedDRA v. 10.1 |
|
| Osteomyelitis | Infections and infestations | MedDRA v. 10.1 |
|
| Pneumonia | Infections and infestations | MedDRA v. 10.1 |
|
| Sinusitis | Infections and infestations | MedDRA v. 10.1 |
|
| Urinary Tract Infection | Infections and infestations | MedDRA v. 10.1 |
|
| Wound Infection Staphylococcal | Infections and infestations | MedDRA v. 10.1 |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v. 10.1 |
|
| Blood Pressure Systolic Increased | Investigations | MedDRA v. 10.1 |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v. 10.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v. 10.1 |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 10.1 |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 10.1 |
|
| Aphasia | Nervous system disorders | MedDRA v. 10.1 |
|
| Balance Disorder | Nervous system disorders | MedDRA v. 10.1 |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA v. 10.1 |
|
| Dizziness | Nervous system disorders | MedDRA v. 10.1 |
|
| Encephalopathy | Nervous system disorders | MedDRA v. 10.1 |
|
| Syncope | Nervous system disorders | MedDRA v. 10.1 |
|
| Homocidal Ideation | Psychiatric disorders | MedDRA v. 10.1 |
|
| Suicide Attempt | Psychiatric disorders | MedDRA v. 10.1 |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA v. 10.1 |
|
| Diabetic Neuropathy | Renal and urinary disorders | MedDRA v. 10.1 |
|
| Urinary Retention | Renal and urinary disorders | MedDRA v. 10.1 |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA v. 10.1 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v. 10.1 |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v. 10.1 |
|
| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA v. 10.1 |
|
| Blood Pressure Fluctuation | Nervous system disorders | MedDRA v. 10.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA v. 10.1 |
|
| Fatigue | General disorders | MedDRA v. 10.1 |
|
| Gait Disturbance | General disorders | MedDRA v. 10.1 |
|
| Oedema Peripheral | General disorders | MedDRA v. 10.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA v. 10.1 |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA v. 10.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v. 10.1 |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v. 10.1 |
|
| Blood Glucose Increased | Investigations | MedDRA v. 10.1 |
|
| Weight Increased | Investigations | MedDRA v. 10.1 |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v. 10.1 |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA v. 10.1 |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 10.1 |
|
| Dizziness | Nervous system disorders | MedDRA v. 10.1 |
|
| Headaches | Nervous system disorders | MedDRA v. 10.1 |
|
| Somnolence | Nervous system disorders | MedDRA v. 10.1 |
|
| Insomnia | Psychiatric disorders | MedDRA v. 10.1 |
|
| Hypertension | Vascular disorders | MedDRA v. 10.1 |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA v. 10.1 |
|
Not provided
Not provided
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Non-responders (No) |
|
| Non-responders (No) |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| Week 8 |
|
| Week 9 |
|
| Week 10 |
|
| Week 11 |
|
| Week 12 |
|
| Week 13 |
|
| Week 14 |
|
| Week 15 |
|
| Week 16 |
|
| Week 17 |
|
| Last On-Treatment Value |
|
| Much improved |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Mental Component Score |
|
| Depression |
|
| No (Not withdrawn) |
|
| No (Allodynia absent) |
|
| No (Did not use rescue analgesic medication) |
|