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The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sativex | Drug | containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline. | Day 7 to Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. | Day 7 to Day 98 |
| Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mick Serpell, MB ChB, FRCA | Pain Clinic Office | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Clinic Office, Gartnavel General Hospital, | Glasgow | West Lothain | G12 0YN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24420962 | Result | Serpell M, Ratcliffe S, Hovorka J, Schofield M, Taylor L, Lauder H, Ehler E. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014 Aug;18(7):999-1012. doi: 10.1002/j.1532-2149.2013.00445.x. Epub 2014 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sativex | Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. |
| FG001 | Placebo | Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sativex | Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. |
| BG001 | Placebo | Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period. |
| 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 Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline. | The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 to Day 98 |
|
All adverse events occurring from the time of consent to post study follow up i.e. 19 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 | Sativex | Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 8.1 | 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 |
| D010523 | Peripheral Nervous System Diseases |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
| Placebo | Drug | containing 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. |
|
|
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline. |
| Day 7 to Day 98 |
| Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score. | Day 7 and Day 98 |
| Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable). | Day 7 and Day 98 |
| Subject Global Impression of Change | A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported. | Day 98 |
| Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment | The BPI-SF 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 higher score represents a poor outcome. | Day 7 and Day 98 |
| Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks) | The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing. | Day 7 and Day 98 |
| Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks) | The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. | Day 7 and Day 98 |
| Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks) | Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment. | Days 0-7 and Days 92-98 |
| Incidence of Adverse Events as a Measure of Subject's Safety. | The number of subjects that reported an adverse event in this study is presented. | 19 weeks |
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Receiving radiotherapy - prostate cancer |
|
| BG002 | 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 delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period. |
|
|
|
| Secondary | Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 to Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 to Day 98 |
|
|
|
|
| Secondary | Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 98 |
|
|
|
|
| Secondary | Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable). | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 98 |
|
|
|
|
| Secondary | Subject Global Impression of Change | A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Number | participants | Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment | The BPI-SF 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 higher score represents a poor outcome. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks) | The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks) | The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks) | Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment. | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | number of tablets | Days 0-7 and Days 92-98 |
|
|
|
|
| Secondary | Incidence of Adverse Events as a Measure of Subject's Safety. | The number of subjects that reported an adverse event in this study is presented. | All subjects were included in this analysis. | Posted | Number | participants | 19 weeks |
|
|
|
| 10 |
| 128 |
| 109 |
| 128 |
| EG001 | Placebo | Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period. | 6 | 118 | 83 | 118 |
| Infective Exacerbation of Chronic Obstructive Airway Disease | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Breast Cancer Stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Enterovesical Fistula | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Lumbar Vertebral fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Soft Tissue Injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Balance Disorder | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 8.1 | 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.
| D009422 | Nervous System Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| Slightly improved |
|
| No change |
|
| Slightly worse |
|
| Much worse |
|