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A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.
This was a multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of GW-1000-02 in central neuropathic pain associated with spinal cord injury. Patients were screened to determine eligibility and completed a seven to 21 day baseline period. Patients then returned to the centre for assessment, randomisation and initial dosing. Visits occurred at the end of treatment week one and at the end of the study (treatment week three) or upon withdrawal. Throughout the study, patients were permitted to take paracetamol as escape analgesic to relieve breakthrough pain. Patients in this study could elect to be screened for an open label extension study of GW-1000-02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW-1000-02 | Experimental | Active treatment. |
|
| Placebo | Placebo Comparator | Placebo control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW-1000-02 | Drug | Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days). | The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline. | Up to 51 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment | The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement. | Up to 51 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal National Orthopaedic Hospital | Middlesex | HA7 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33465022 | Derived | Thomas PA, Carter GT, Bombardier CH. A scoping review on the effect of cannabis on pain intensity in people with spinal cord injury. J Spinal Cord Med. 2022 Sep;45(5):656-667. doi: 10.1080/10790268.2020.1865709. Epub 2021 Jan 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GW-1000-02 | Each actuation of oromucosal spray delivers 2.7mg 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 130 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 Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days). | The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
All adverse events occurring from the time of consent to post study follow up (0-61 days) 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 | Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Not Otherwise Specified Aggravated | Blood and lymphatic system disorders | MedDRA 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 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 |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
|
| Placebo | Drug | Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period. |
|
| Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment |
Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement. |
| Up to 51 days |
| Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment | Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement. | Up to 51 days |
| Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment. | Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline. | 0 - 51 days |
| Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment | Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement. | Up to 51 days |
| Change From Baseline in Modified Ashworth Scale Score at the End of Treatment | The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline. | Up to 51 days |
| Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment | Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function . A negative value from baseline indicates a deterioration. | Up to 51 days |
| Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment | 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 is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline. | Up to 51 days |
| Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment | Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement. | Up to 51 days |
| Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment | The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented. | Up to 51 days |
| Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment | The Brief Pain Inventory 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 is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline. | 0 - 51 days |
| Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment | Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline. | 0 - 51 days |
| Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event during the study is presented. | Up to 61 days |
| Personal problems |
|
| Problems with administration |
|
| 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 |
|
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
| OG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. |
|
|
|
| Secondary | Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment | The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | percentage of days | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment | Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment | Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | percentage of days | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment. | Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment | Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | percentage of days | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in Modified Ashworth Scale Score at the End of Treatment | The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment | Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function . A negative value from baseline indicates a deterioration. | All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment | 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 is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline. | All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment | Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement. | All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 51 days |
|
|
|
|
| Secondary | Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment | The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented. | All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis. | Posted | Number | participants | Up to 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment | The Brief Pain Inventory 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 is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 51 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment | Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline. | All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 51 days |
|
|
|
| Secondary | Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event during the study is presented. | All randomised patients who received at least one dose of study drug were included in the Safety population. | Posted | Number | participants | Up to 61 days |
|
|
|
| 3 |
| 56 |
| 46 |
| 56 |
| EG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. | 2 | 60 | 29 | 60 |
| Fall | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Methicillin-resistant Staphylococcus aureus infection | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Bladder Infection Not Otherwise Specified | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Pneumonia Not Otherwise Specified | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 5.0 | Systematic Assessment |
|
| Upper Limb Fracture Not Otherwise Specified | Injury, poisoning and procedural complications | MedDRA 5.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Contusion | Skin and subcutaneous tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Feeling Abnormal | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Urinary Tract Infection Not Otherwise Specified | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Headache Not Otherwise Specified | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 5.0 | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Vomiting 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 |
|
| Pain Exacerbated | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Feeling of Relaxation | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Blood Sodium Decreased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Haematocrit Decreased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Red Blood Cell Count Decreased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Neutrophil Count Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Speech Disorder | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Flushing | 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.