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Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.
Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW-1000-02 | Experimental | Active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW-1000-02 | Drug | Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and 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 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events as a Measure of Subject Safety. | Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented. | Up to 1051 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | 0 - 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Serpell, ChB FRCA | Gartnavel General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gartnavel General Hospital | Glasgow | G12 0YN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22878432 | Result | Serpell MG, Notcutt W, Collin C. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis. J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 10. |
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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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GW-1000-02 | Active treatment |
| 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 | Incidence of Adverse Events as a Measure of Subject Safety. | Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented. | All subjects who took part in the extension study were included in the analysis. | Posted | Number | participants | Up to 1051 days |
|
|
All adverse events occurring from the extension study onset to the last study visit (up to 1051 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 | Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 6.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 6.0 | 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 |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
|
| Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | 0 - 52 weeks. |
| Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | 0 - 52 weeks. |
| Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | 0 - 52 weeks. |
| Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | Up to 1051 days |
| Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | Up to 1051 days |
| Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | Up to 1051 days |
| Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | Up to 1051days |
| Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | Up to 1051 |
| Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | Up to 1051 days |
| Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | Up to 1051 days |
| Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | Up to 1051 days. |
| Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | Up to 1051 days |
| Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | Up to 1051 days. |
| Investigator Global Assessment at the Last Study Visit in Subjects With Pain. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | Up to 1051 days. |
| Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | Up to 1051 days. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Patient non-compliance |
|
| Death |
|
| Decreased/no pain |
|
| Issues with driving |
|
| multiple sclerosis less stable |
|
| Increased bilirubin |
|
| Spray causes nausea |
|
| Not enough improvement |
|
| Wanted to try another treatment |
|
| Patient leaving country |
|
| Personal reasons |
|
| Unable to tolerate study med. taste |
|
| Patient moving |
|
| Unable to collect consistent data |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 52 weeks |
|
|
|
| Secondary | Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 52 weeks. |
|
|
|
| Secondary | Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 52 weeks. |
|
|
|
| Secondary | Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment. | Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline. | All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 - 52 weeks. |
|
|
|
| Secondary | Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051days |
|
|
|
| Secondary | Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 |
|
|
|
| Secondary | Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented. | All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects. | Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented. | All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days. |
|
|
|
| Secondary | Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | All subjects who entered the study from a parent RCT investigation neuropathic pain due to multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days |
|
|
|
| Secondary | Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days. |
|
|
|
| Secondary | Investigator Global Assessment at the Last Study Visit in Subjects With Pain. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days. |
|
|
|
| Secondary | Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis. | Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented. | All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis. | Posted | Number | participants | Up to 1051 days. |
|
|
|
| 74 |
| 507 |
| 477 |
| 507 |
| VENTRICULAR BIGEMINY | Cardiac disorders | MedDRA 6.0 | Systematic Assessment |
|
| CORNEAL ULCER | Eye disorders | MedDRA 6.0 | Systematic Assessment |
|
| EYELID OEDEMA | Eye disorders | MedDRA 6.0 | Systematic Assessment |
|
| ABDOMINAL PAIN NOT OTHERWISE SPECIFIED (NOS) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| DIARRHOEA NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| VOMITING NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| CONSTIPATION AGGRAVATED | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| OESOPHAGITIS NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| SMALL INTESTINAL GANGRENE NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| WEAKNESS | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| PAIN EXACERBATED | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 6.0 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 6.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| SEPSIS NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| BRONCHOPNEUMONIA NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| GASTROENTERITIS NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| INFECTION NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| PNEUMONIA NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| POST PROCEDURAL SITE WOUND INFECTION | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| DEVICE FAILURE | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| FRACTURED PELVIS NOS | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| INCISIONAL HERNIA NOS | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| MEDICAL DEVICE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| POST PROCEDURAL URINE LEAK | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| LIVER FUNCTION TESTS NOS ABNORMAL | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| BLOOD IN STOOL | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA NOS | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| INGUINAL MASS | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| LUNG CANCER STAGE UNSPECIFIED (EXCL METASTATIC TUMOURS TO LUNG) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS AGGRAVATED | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| CONVULSIONS NOS | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| DYSARTHRIA | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| DELUSIONAL PERCEPTION | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| PARANOIA | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 6.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE ON CHRONIC | Renal and urinary disorders | MedDRA 6.0 | Systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| URTICARIA NOS | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| PREGNANCY OF PARTNER | Social circumstances | MedDRA 6.0 | Systematic Assessment |
|
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 6.0 | Systematic Assessment |
|
| DEEP VENOUS THROMBOSIS NOS | Vascular disorders | MedDRA 6.0 | Systematic Assessment |
|
| Headache Not Otherwise Specified (NOS) | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Multiple Sclerosis Aggravated | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Balance Impaired NOS | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Mouth Ulceration | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Tooth Discolouration | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Weakness | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pain Exacerbated | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Urinary Tract Infection NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection NOS | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pain in Limb | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase Increased | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase NOS Increased | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| Contusion | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | 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.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |