Trial Outcomes & Findings for A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis (NCT NCT01610687)

NCT ID: NCT01610687

Last Updated: 2023-01-10

Results Overview

The number of patients who experienced an adverse event during the course of this extension study is presented

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

137 participants

Primary outcome timeframe

up to1206 days

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	GW-1000-02 GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Study STARTED	137
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Reasons for withdrawal
Measure	GW-1000-02 GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Study Lack of Efficacy	26
Overall Study Adverse Event	18
Overall Study Moved out of area	6
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	4
Overall Study Symptom control without study medication	2
Overall Study Unable to make journey	1
Overall Study Death	1
Overall Study Cannabis affecting job	1
Overall Study Felt more alter without study medication	1

Baseline Characteristics

A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GW-1000-02 n=137 Participants Active treatment
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age, Continuous	50.69 years STANDARD_DEVIATION 9.531 • n=99 Participants
Sex: Female, Male Female	83 Participants n=99 Participants
Sex: Female, Male Male	54 Participants n=99 Participants
Region of Enrollment United Kingdom	137 participants n=99 Participants

PRIMARY outcome

Timeframe: up to1206 days

Population: All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.

The number of patients who experienced an adverse event during the course of this extension study is presented

Outcome measures

Outcome measures
Measure	GW-1000-02 n=137 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Incidence of Adverse Events as a Measure of Patient Safety	126 participants

SECONDARY outcome

Timeframe: up to 1206 days

A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=137 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment	8.09 sprays of study medication Standard Deviation 7.91

SECONDARY outcome

Timeframe: 18 weeks

Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=121 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.	2.65 units on a scale Standard Deviation 14.15

SECONDARY outcome

Timeframe: week 18

The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=135 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Investigator Assessed Global Severity Score at Week 18	92 participants

SECONDARY outcome

Timeframe: week 18

A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=74 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18	-31.34 units on a scale Standard Deviation 27.20

SECONDARY outcome

Timeframe: week 18

A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=118 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18	-27.81 units on a scale Standard Deviation 24.46

SECONDARY outcome

Timeframe: week 18

A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=43 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18	-26.23 units on a scale Standard Deviation 23.90

SECONDARY outcome

Timeframe: 18 weeks

A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=96 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18	-33.60 units on a scale Standard Deviation 25.12

Adverse Events

GW-1000-02

Serious events: 23 serious events

Other events: 127 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GW-1000-02 n=137 participants at risk Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Infections and infestations Urinary Tract Infection Not Otherwise Specified (NOS)	2.9% 4/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations Pneumonia NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations Bone infection NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations Cellulitis	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders Multiple Sclerosis Relapse	2.2% 3/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders Balance Impaired NOS	1.5% 2/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders Convulsions NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders Hypotonia	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders Fall	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders Oedema Peripheral	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders Weakness	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Injury, poisoning and procedural complications Femur Fracture	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Injury, poisoning and procedural complications Lower Limb Fracture NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.5% 2/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders Muscle Weakness NOS	1.5% 2/137 • All adverse events occurring from during the extension study (up to 1049 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Stage Unspecified (excl metastatic tumours to lung)	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders Vomiting NOS	1.5% 2/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders Diarrhoea NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Blood and lymphatic system disorders Lymphadenopathy	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Cardiac disorders Atrial Fibrillation	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Hepatobiliary disorders Biliary Cirrhosis Primary	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Metabolism and nutrition disorders Dehydration	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders Panic Attack	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders Psychotic Disorder NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Skin and subcutaneous tissue disorders Decubitus Ulcer	1.5% 2/137 • All adverse events occurring from during the extension study (up to 1049 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.
Vascular disorders Deep Vein Thrombosis NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Injury, poisoning and procedural complications Head Injury	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Metabolism and nutrition disorders Hyperglycaemia NOS	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.73% 1/137 • All adverse events occurring from during the extension study (up to 1049 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.

Other adverse events

Other adverse events
Measure	GW-1000-02 n=137 participants at risk Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Gastrointestinal disorders ORAL PAIN	23.4% 32/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders DIARRHOEA NOS	19.7% 27/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders NAUSEA	17.5% 24/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders VOMITING NOS	11.7% 16/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders GLOSSODYNIA	10.9% 15/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders ORAL MUCOSAL DISORDER	10.9% 15/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders CONSTIPATION	8.8% 12/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders DRY MOUTH	8.0% 11/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders ORAL DISCOMFORT	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders MOUTH ULCERATION	5.8% 8/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders DYSPEPSIA	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders LOOSE STOOLS	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders TOOTHACHE	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Gastrointestinal disorders TOOTH DISCOLOURATION	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders FALL	15.3% 21/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders FATIGUE	11.7% 16/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders WEAKNESS	8.0% 11/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders LETHARGY	7.3% 10/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders APPLICATION SITE IRRITATION	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders APPLICATION SITE PAIN	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders MALAISE	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
General disorders FEELING ABNORMAL	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations URINARY TRACT INFECTION NOS	40.9% 56/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations NASOPHARYNGITIS	27.0% 37/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION NOS	9.5% 13/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations TOOTH CARIES NOS	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations BACTERIAL INFECTION NOS	5.8% 8/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations BLADDER INFECTION NOS	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations VAGINAL CANDIDIASIS	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
Infections and infestations VIRAL INFECTION NOS	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Investigations WEIGHT DECREASED	9.5% 13/137 • All adverse events occurring from during the extension study (up to 1049 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.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	7.3% 10/137 • All adverse events occurring from during the extension study (up to 1049 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.
Metabolism and nutrition disorders ANOREXIA	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders PAIN IN LIMB	12.4% 17/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS NOS	9.5% 13/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders ARTHRALGIA	8.8% 12/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders BACK PAIN	7.3% 10/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders JOINT SWELLING	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders MYALGIA	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Musculoskeletal and connective tissue disorders PERIPHERAL SWELLING	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders DIZZINESS	21.9% 30/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders HEADACHE NOS	16.8% 23/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders BALANCE IMPAIRED NOS	15.3% 21/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders MULTIPLE SCLEROSIS AGGRAVATED	11.7% 16/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders DYSGEUSIA	9.5% 13/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	8.8% 12/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders DISTURBANCE IN ATTENTION	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders SOMNOLENCE	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders SYNCOPE	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Nervous system disorders MEMORY IMPAIRMENT	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders SHORT-TERM MEMORY LOSS	6.6% 9/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders DEPRESSED MOOD	5.1% 7/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders DISORIENTATION	4.4% 6/137 • All adverse events occurring from during the extension study (up to 1049 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.
Psychiatric disorders INSOMNIA	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Respiratory, thoracic and mediastinal disorders PHARYNGITIS	5.8% 8/137 • All adverse events occurring from during the extension study (up to 1049 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.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	3.6% 5/137 • All adverse events occurring from during the extension study (up to 1049 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.
Skin and subcutaneous tissue disorders CONTUSION	8.8% 12/137 • All adverse events occurring from during the extension study (up to 1049 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.

Additional Information

Mr Richard Potts, Clinical Operations Director

GW Pharma Ltd.

Phone: 0044 1223 266800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER