Trial Outcomes & Findings for A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy (NCT NCT00674609)
NCT ID: NCT00674609
Last Updated: 2023-05-03
Results Overview
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
2 weeks: baseline - end of week 2 (last 3 days of treatment)
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Sativex
Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
|
THC Alone
Each 100 uL actuation contained 27 mg/ml THC
|
Placebo
Each 100 uL actuation contained colourant and excipients
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
59
|
|
Overall Study
COMPLETED
|
48
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
Baseline characteristics by cohort
| Measure |
Sativex
n=60 Participants
Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
|
THC Alone
n=58 Participants
Each 100 uL actuation contained 27 mg/ml THC
|
Placebo
n=59 Participants
Each 100 uL actuation contained colourant and excipients
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 12.08 • n=99 Participants
|
61.3 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
60.1 years
STANDARD_DEVIATION 12.31 • n=206 Participants
|
60.2 years
STANDARD_DEVIATION 12.25 • n=7 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=99 Participants
|
18 participants
n=107 Participants
|
21 participants
n=206 Participants
|
61 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Region of Enrollment
Romania
|
34 participants
n=99 Participants
|
36 participants
n=107 Participants
|
35 participants
n=206 Participants
|
105 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 weeks: baseline - end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Outcome measures
| Measure |
Sativex
n=53 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=52 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
|
-1.32 units on a scale
Standard Deviation 1.64 • Interval -1.44 to -0.14
|
-0.93 units on a scale
Standard Deviation 1.15 • Interval -1.02 to 0.19
|
-0.73 units on a scale
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: 2 weeks: baseline - end of week 2 (last 3 days of treatment)Population: The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.
Subjects recorded their use of escape medication each day on their diary card.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=52 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=57 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
The Consumption of Escape Analgesic Medication.
|
0.72 tablets per day
Standard Deviation 0.821 • Interval -0.25 to 0.16
|
0.88 tablets per day
Standard Deviation 0.852 • Interval -0.19 to 0.22
|
0.68 tablets per day
Standard Deviation 0.662
|
SECONDARY outcome
Timeframe: 2 weeks: baseline to end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=54 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Sleep Disturbance 0-10 Numerical Rating Scale
|
-0.59 units on a scale
Standard Deviation 1.88 • Interval -0.97 to 0.34
|
-0.25 units on a scale
Standard Deviation 2.33 • Interval -0.64 to 0.68
|
-0.21 units on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 2 weeks; baseline - end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=54 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Nausea 0-10 Numerical Rating Scale
|
0 units on a scale
Standard Deviation 2.19 • Interval -0.11 to 1.09
|
0.27 units on a scale
Standard Deviation 1.83 • Interval -0.13 to 1.05
|
-0.16 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 2 weeks: baseline - end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=54 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Memory 0-10 Numerical Rating Scale
|
0.58 units on a scale
Standard Deviation 2.06
|
0.57 units on a scale
Standard Deviation 1.90
|
0 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 2 weeks: baseline - end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=54 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Appetite 0-10 Numerical Rating Scale
|
0.24 units on a scale
Standard Deviation 2.29
|
0.18 units on a scale
Standard Deviation 1.91
|
-1.65 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: 2 weeks: baseline - end of week 2 (last 3 days of treatment)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Outcome measures
| Measure |
Sativex
n=54 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=54 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=56 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Concentration 0-10 Numerical Rating Scale
|
0.26 units on a scale
Standard Deviation 1.66
|
0.22 units on a scale
Standard Deviation 1.80
|
-0.32 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: 2 weeks; baseline and end of treatment (2 weeks)Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Outcome measures
| Measure |
Sativex
n=49 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=50 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=52 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
EORTC Quality of Life Questionnaire (EORTC-QLQC30)
|
4.93 units on a scale
Standard Deviation 17.51
|
3.57 units on a scale
Standard Deviation 18.32
|
4.74 units on a scale
Standard Deviation 18.50
|
SECONDARY outcome
Timeframe: End of 2 weeksPopulation: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Outcome measures
| Measure |
Sativex
n=15 Participants
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
|
THC Alone
n=17 Participants
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
|
Placebo
n=18 Participants
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|---|
|
Brief Pain Inventory Short Form
|
0.2 units on a scale
Standard Deviation 5.63
|
-3.38 units on a scale
Standard Deviation 6.43
|
0.41 units on a scale
Standard Deviation 5.55
|
Adverse Events
Sativex
Serious events: 13 serious events
Other events: 51 other events
Deaths: 0 deaths
THC Alone
Serious events: 13 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sativex
n=60 participants at risk
Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
|
THC Alone
n=58 participants at risk
Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
|
Placebo
n=59 participants at risk
Maximum number of daily sprays was 48
|
|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea aggravated
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Disease progression nos
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Chest pain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Malaise
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Weakness
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Bronchopneumonia nos
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Investigations
Blood urine present
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Neoplasm progression nos
|
10.0%
6/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
8.6%
5/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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 neoplasm progression
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Metastases to brain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Metastases to prostate
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Tumour haemorrhage
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Tumour pain
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Spinal cord compression nos
|
1.7%
1/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Syncope
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Tremor
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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
|
3.3%
2/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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 nos
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea nos
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Social circumstances
Family stress nos
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
Sativex
n=60 participants at risk
Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
|
THC Alone
n=58 participants at risk
Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
|
Placebo
n=59 participants at risk
Maximum number of daily sprays was 48
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
15.0%
9/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
13.8%
8/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
13.6%
8/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
7/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
10.3%
6/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
10.2%
6/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dizziness
|
11.7%
7/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
12.1%
7/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
3/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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)
Neoplasm progression NOS
|
10.0%
6/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
8.6%
5/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
3/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
5/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
6.9%
4/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
6.8%
4/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Confusion
|
6.7%
4/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
6.7%
4/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
10.2%
6/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Investigations
Liver function test NOS abnormal
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Weakness
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
Hypotension NOS
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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
|
5.0%
3/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Oral pain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
8.6%
5/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
3/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Glossodynia
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
8.6%
5/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
8.6%
5/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
3/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.2%
3/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Chest Pain
|
0.00%
0/60 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.2%
3/58 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
All AEs 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