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To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.
Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW-1000-02 | Experimental | Each 100 μl actuation contains 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose was 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). |
|
| Placebo | Placebo Comparator | Each 100 μl actuation contains the excipients only. The maximum permitted dose was 48 actuations in any 24 hour period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW-1000-02 | Drug | Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks. | Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement. | 0 - 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Analgesic Escape Medication. | The percentage of days on treatment on which escape medication was used is presented. | 0 - 3 weeks |
| Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Paget Hospital | Norfolk | NR31 6LA | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | GW-1000-02 | Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg). |
| FG001 | Placebo | Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GW-1000-02 | Active treatment. |
| BG001 | Placebo | Placebo control. |
| BG002 |
| 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 From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks. | Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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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 | GW-1000-02 | Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis Not Otherwise Specified | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharma Ltd. | 0044 1223 266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
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| Placebo | Drug | Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period. |
|
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
| 0 - 3 weeks |
| Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks. | The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement. | 0 - 3 weeks |
| Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks. | The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement. | 0 - 3 weeks |
| Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks. | The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement. | 0 - 3 weeks |
| Patient Global Impression of Change at the End of 3 Weeks of Treatment. | The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented. | 0 - 3 weeks |
| Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks. | Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement. | 0 - 3 weeks |
| Use of Analgesic Escape Medication - Multiple Sclerosis Subset. | The percentage of days on treatment on which escape medication was used is presented. | 0 - 3 weeks |
| Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks. | Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement. | 0 - 3 weeks |
| Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks. | The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement. | 0 - 3 weeks |
| Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks. | The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement. | 0 - 3 weeks |
| Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks. | The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement. | 0 - 3 weeks |
| Patient Global Impression of Change - Multiple Sclerosis Subset. | The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented. | 0 - 3 weeks |
| Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event in the study is presented. | 0 - 65 days |
| Withdrawal by Subject |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period. |
|
|
|
| Secondary | Use of Analgesic Escape Medication. | The percentage of days on treatment on which escape medication was used is presented. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | percentage of days | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks. | Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks. | The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks. | The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks. | The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Patient Global Impression of Change at the End of 3 Weeks of Treatment. | The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented. | All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis. | Posted | Number | participants | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks. | Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Use of Analgesic Escape Medication - Multiple Sclerosis Subset. | The percentage of days on treatment on which escape medication was used is presented. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | percentage of days | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks. | Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks. | The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks. | The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks. | The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 3 weeks |
|
|
|
|
| Secondary | Patient Global Impression of Change - Multiple Sclerosis Subset. | The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented. | Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis. | Posted | Number | participants | 0 - 3 weeks |
|
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|
|
| Secondary | Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event in the study is presented. | All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis. | Posted | Number | participants | 0 - 65 days |
|
|
|
| 0 |
| 36 |
| 35 |
| 36 |
| EG001 | Placebo | Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period. | 1 | 34 | 26 | 34 |
| Urinary Tract Infection Not Otherwise Specified | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Headache Not Otherwise Specified | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Gait Abnormal Not Otherwise Specified | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
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| Oral Pain | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Vomiting Not Otherwise Specified | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Diarrhoea Not Otherwise Specified | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA 5.0 | Systematic Assessment |
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| Application Site Burning | General disorders | MedDRA 5.0 | Systematic Assessment |
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| Feeling of Relaxation | General disorders | MedDRA 5.0 | Systematic Assessment |
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| Lethargy | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 5.0 | Systematic Assessment |
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| Weakness | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
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| Paranoia | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Appetite Increased | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 5.0 | Systematic Assessment |
|
| Pain in Limb | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
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| Back Pain Aggravated | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Peripheral Swelling | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Hypertension Not Otherwise Specified | Vascular disorders | MedDRA 5.0 | Systematic Assessment |
|
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |