Trial Outcomes & Findings for A Study of the Long-term Safety of Sativex Use (NCT NCT01606137)
NCT ID: NCT01606137
Last Updated: 2023-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
Up to 1051 days
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
507
|
|
Overall Study
COMPLETED
|
245
|
|
Overall Study
NOT COMPLETED
|
262
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Adverse Event
|
85
|
|
Overall Study
Withdrawal by Subject
|
74
|
|
Overall Study
Lack of Efficacy
|
56
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Patient non-compliance
|
9
|
|
Overall Study
Death
|
1
|
|
Overall Study
Decreased/no pain
|
4
|
|
Overall Study
Issues with driving
|
4
|
|
Overall Study
multiple sclerosis less stable
|
1
|
|
Overall Study
Increased bilirubin
|
1
|
|
Overall Study
Spray causes nausea
|
1
|
|
Overall Study
Not enough improvement
|
4
|
|
Overall Study
Wanted to try another treatment
|
1
|
|
Overall Study
Patient leaving country
|
1
|
|
Overall Study
Personal reasons
|
1
|
|
Overall Study
Unable to tolerate study med. taste
|
1
|
|
Overall Study
Patient moving
|
1
|
|
Overall Study
Unable to collect consistent data
|
1
|
Baseline Characteristics
A Study of the Long-term Safety of Sativex Use
Baseline characteristics by cohort
| Measure |
GW-1000-02
n=507 Participants
Active treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
458 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
288 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
507 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1051 daysPopulation: All subjects who took part in the extension study were included in the analysis.
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.
Outcome measures
| Measure |
GW-1000-02
n=507 Participants
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.
|
|---|---|
|
Incidence of Adverse Events as a Measure of Subject Safety.
|
477 participants
|
SECONDARY outcome
Timeframe: 0 - 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=61 Participants
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.
|
|---|---|
|
Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.
|
-1.83 units on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: 0 - 52 weeks.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=62 Participants
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.
|
|---|---|
|
Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
|
-2.96 units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: 0 - 52 weeks.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=63 Participants
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.
|
|---|---|
|
Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.
|
-3.11 units on a scale
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: 0 - 52 weeks.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=131 Participants
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.
|
|---|---|
|
Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
|
-2.57 units on a scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=98 Participants
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.
|
|---|---|
|
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
|
75 participants
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=98 Participants
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.
|
|---|---|
|
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
|
76 participants
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=168 Participants
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.
|
|---|---|
|
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
|
112 participants
|
SECONDARY outcome
Timeframe: Up to 1051daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=168 Participants
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.
|
|---|---|
|
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
|
111 participants
|
SECONDARY outcome
Timeframe: Up to 1051Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=314 Participants
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.
|
|---|---|
|
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
|
193 participants
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=314 Participants
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.
|
|---|---|
|
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
|
190 participants
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=286 Participants
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.
|
|---|---|
|
Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
|
199 participants
|
SECONDARY outcome
Timeframe: Up to 1051 days.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=287 Participants
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.
|
|---|---|
|
Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
|
200 participants
|
SECONDARY outcome
Timeframe: Up to 1051 daysPopulation: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=98 Participants
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.
|
|---|---|
|
Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.
|
30 participants
|
SECONDARY outcome
Timeframe: Up to 1051 days.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=166 Participants
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.
|
|---|---|
|
Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.
|
83 participants
|
SECONDARY outcome
Timeframe: Up to 1051 days.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=312 Participants
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.
|
|---|---|
|
Investigator Global Assessment at the Last Study Visit in Subjects With Pain.
|
122 participants
|
SECONDARY outcome
Timeframe: Up to 1051 days.Population: 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.
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.
Outcome measures
| Measure |
GW-1000-02
n=284 Participants
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.
|
|---|---|
|
Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.
|
87 participants
|
Adverse Events
GW-1000-02
Serious events: 74 serious events
Other events: 477 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GW-1000-02
n=507 participants at risk
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.
|
|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.20%
1/507 • 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.
|
|
Cardiac disorders
VENTRICULAR BIGEMINY
|
0.20%
1/507 • 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.
|
|
Eye disorders
CORNEAL ULCER
|
0.20%
1/507 • 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.
|
|
Eye disorders
EYELID OEDEMA
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN NOT OTHERWISE SPECIFIED (NOS)
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
DIARRHOEA NOS
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
NAUSEA
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
VOMITING NOS
|
0.39%
2/507 • 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.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
CONSTIPATION AGGRAVATED
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
OESOPHAGITIS NOS
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
SMALL INTESTINAL GANGRENE NOS
|
0.20%
1/507 • 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.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION NOS
|
0.20%
1/507 • 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.
|
|
General disorders
CHEST PAIN
|
0.39%
2/507 • 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.
|
|
General disorders
WEAKNESS
|
0.39%
2/507 • 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.
|
|
General disorders
PAIN EXACERBATED
|
0.20%
1/507 • 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.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.20%
1/507 • 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.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.39%
2/507 • 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.
|
|
Infections and infestations
URINARY TRACT INFECTION NOS
|
2.8%
14/507 • 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.
|
|
Infections and infestations
SEPSIS NOS
|
0.39%
2/507 • 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.
|
|
Infections and infestations
BRONCHOPNEUMONIA NOS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
CELLULITIS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
GASTROENTERITIS NOS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
INFECTION NOS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION NOS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
PNEUMONIA NOS
|
0.20%
1/507 • 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.
|
|
Infections and infestations
POST PROCEDURAL SITE WOUND INFECTION
|
0.20%
1/507 • 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.
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.39%
2/507 • 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.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
DEVICE FAILURE
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
FRACTURED PELVIS NOS
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA NOS
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.20%
1/507 • 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.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL URINE LEAK
|
0.20%
1/507 • 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.
|
|
Investigations
LIVER FUNCTION TESTS NOS ABNORMAL
|
0.39%
2/507 • 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.
|
|
Investigations
BLOOD IN STOOL
|
0.20%
1/507 • 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.
|
|
Investigations
WEIGHT DECREASED
|
0.20%
1/507 • 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.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA NOS
|
0.39%
2/507 • 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.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.20%
1/507 • 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.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.20%
1/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.20%
1/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
INGUINAL MASS
|
0.20%
1/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.20%
1/507 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER STAGE UNSPECIFIED (EXCL METASTATIC TUMOURS TO LUNG)
|
0.20%
1/507 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.20%
1/507 • 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.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
0.99%
5/507 • 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.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS AGGRAVATED
|
0.79%
4/507 • 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.
|
|
Nervous system disorders
CONVULSIONS NOS
|
0.39%
2/507 • 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.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.39%
2/507 • 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.
|
|
Nervous system disorders
DIZZINESS
|
0.39%
2/507 • 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.
|
|
Nervous system disorders
DYSARTHRIA
|
0.39%
2/507 • 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.
|
|
Nervous system disorders
SOMNOLENCE
|
0.39%
2/507 • 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.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.20%
1/507 • 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.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.20%
1/507 • 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.
|
|
Nervous system disorders
PARAESTHESIA
|
0.20%
1/507 • 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.
|
|
Nervous system disorders
TREMOR
|
0.20%
1/507 • 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.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.39%
2/507 • 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.
|
|
Psychiatric disorders
DELUSIONAL PERCEPTION
|
0.20%
1/507 • 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.
|
|
Psychiatric disorders
PARANOIA
|
0.20%
1/507 • 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.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.39%
2/507 • 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.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE ON CHRONIC
|
0.20%
1/507 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.39%
2/507 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.20%
1/507 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.20%
1/507 • 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.
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.20%
1/507 • 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.
|
|
Skin and subcutaneous tissue disorders
URTICARIA NOS
|
0.20%
1/507 • 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.
|
|
Social circumstances
PREGNANCY OF PARTNER
|
0.79%
4/507 • 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.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.20%
1/507 • 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.
|
|
Vascular disorders
DEEP VENOUS THROMBOSIS NOS
|
0.20%
1/507 • 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.
|
Other adverse events
| Measure |
GW-1000-02
n=507 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Dizziness
|
28.4%
144/507 • 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.
|
|
Nervous system disorders
Headache Not Otherwise Specified (NOS)
|
11.0%
56/507 • 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.
|
|
Nervous system disorders
Somnolence
|
8.5%
43/507 • 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.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
39/507 • 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.
|
|
Nervous system disorders
Multiple Sclerosis Aggravated
|
7.7%
39/507 • 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.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
5.9%
30/507 • 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.
|
|
Nervous system disorders
Balance Impaired NOS
|
5.3%
27/507 • 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.
|
|
Nervous system disorders
Memory Impairment
|
3.6%
18/507 • 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.
|
|
Nervous system disorders
Disturbance in Attention
|
3.4%
17/507 • 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.
|
|
Gastrointestinal disorders
Nausea
|
17.2%
87/507 • 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.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
11.8%
60/507 • 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.
|
|
Gastrointestinal disorders
Vomiting NOS
|
10.8%
55/507 • 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.
|
|
Gastrointestinal disorders
Dry Mouth
|
8.5%
43/507 • 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.
|
|
Nervous system disorders
Mouth Ulceration
|
5.5%
28/507 • 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.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
27/507 • 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.
|
|
Gastrointestinal disorders
Glossodynia
|
5.1%
26/507 • 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.
|
|
Gastrointestinal disorders
Oral Pain
|
4.7%
24/507 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
23/507 • 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.
|
|
Gastrointestinal disorders
Tooth Discolouration
|
3.7%
19/507 • 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.
|
|
General disorders
Fatigue
|
12.0%
61/507 • 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.
|
|
General disorders
Weakness
|
6.7%
34/507 • 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.
|
|
General disorders
Fall
|
5.1%
26/507 • 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.
|
|
General disorders
Pain Exacerbated
|
4.9%
25/507 • 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.
|
|
General disorders
Feeling Drunk
|
4.9%
25/507 • 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.
|
|
General disorders
Application Site Pain
|
4.7%
24/507 • 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.
|
|
General disorders
Lethargy
|
3.6%
18/507 • 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.
|
|
General disorders
Oedema Peripheral
|
3.4%
17/507 • 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.
|
|
General disorders
Influenza Like Illness
|
3.2%
16/507 • 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.
|
|
General disorders
Malaise
|
3.2%
16/507 • 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.
|
|
Infections and infestations
Urinary Tract Infection NOS
|
21.9%
111/507 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
40/507 • 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.
|
|
Infections and infestations
Lower Respiratory Tract Infection NOS
|
5.9%
30/507 • 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.
|
|
Infections and infestations
Influenza
|
3.7%
19/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.9%
35/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
31/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
27/507 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Limb
|
4.7%
24/507 • 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.
|
|
Psychiatric disorders
Euphoric Mood
|
4.3%
22/507 • 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.
|
|
Psychiatric disorders
Depression
|
3.9%
20/507 • 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.
|
|
Psychiatric disorders
Depressed Mood
|
3.6%
18/507 • 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.
|
|
Psychiatric disorders
Insomnia
|
3.6%
18/507 • 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.
|
|
Psychiatric disorders
Anxiety
|
3.0%
15/507 • 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.
|
|
Investigations
Gamma-glutamyltransferase Increased
|
5.1%
26/507 • 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.
|
|
Investigations
Weight Decreased
|
3.9%
20/507 • 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.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.2%
16/507 • 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.
|
|
Investigations
Blood Alkaline Phosphatase NOS Increased
|
2.6%
13/507 • 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.
|
|
Skin and subcutaneous tissue disorders
Contusion
|
3.2%
16/507 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
3.2%
16/507 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.1%
26/507 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
18/507 • 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.
|
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