Trial Outcomes & Findings for GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes (NCT NCT01217112)
NCT ID: NCT01217112
Last Updated: 2022-10-18
Results Overview
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Baseline (Day 1) and End of treatment (Day 92)
Results posted on
2022-10-18
Participant Flow
Participant milestones
| Measure |
1:1 GWP42003 : GWP42004
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
Contains excipients only
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
13
|
12
|
14
|
|
Overall Study
COMPLETED
|
11
|
10
|
12
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
1:1 GWP42003 : GWP42004
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
Contains excipients only
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
Baseline characteristics by cohort
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Age, Continuous
|
59.33 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
57.96 years
STANDARD_DEVIATION 8.11 • n=7 Participants
|
56.80 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
62.45 years
STANDARD_DEVIATION 12.58 • n=4 Participants
|
58.63 years
STANDARD_DEVIATION 7.72 • n=21 Participants
|
58.98 years
STANDARD_DEVIATION 9.41 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
14 participants
n=21 Participants
|
62 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
|
0.00 mmol/l
Standard Deviation 0.09
|
0.04 mmol/l
Standard Deviation 0.07
|
-0.04 mmol/l
Standard Deviation 0.14
|
0.00 mmol/l
Standard Deviation 0.14
|
0.02 mmol/l
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.04 mmol/l
Standard Deviation 0.12
|
-0.06 mmol/l
Standard Deviation 0.08
|
-0.11 mmol/l
Standard Deviation 0.08
|
-0.01 mmol/l
Standard Deviation 0.16
|
-0.02 mmol/l
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
|
-0.53 mmol/l
Standard Deviation 0.78
|
-0.27 mmol/l
Standard Deviation 0.32
|
-0.22 mmol/l
Standard Deviation 0.50
|
-0.13 mmol/l
Standard Deviation 0.44
|
-0.09 mmol/l
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.12 mmol/l
Standard Deviation 0.83
|
-0.23 mmol/l
Standard Deviation 0.28
|
-0.11 mmol/l
Standard Deviation 0.52
|
-0.11 mmol/l
Standard Deviation 0.45
|
-0.16 mmol/l
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=8 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=11 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
|
-0.29 mmol/l
Standard Deviation 0.62
|
-0.13 mmol/l
Standard Deviation 0.36
|
-0.11 mmol/l
Standard Deviation 0.40
|
-0.02 mmol/l
Standard Deviation 0.50
|
0.07 mmol/l
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.03 mmol/l
Standard Deviation 0.49
|
-0.16 mmol/l
Standard Deviation 0.26
|
-0.08 mmol/l
Standard Deviation 0.43
|
-0.08 mmol/l
Standard Deviation 0.41
|
-0.06 mmol/l
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=8 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=11 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
|
0.03 ratio
Standard Deviation 0.11
|
0.04 ratio
Standard Deviation 0.05
|
-0.02 ratio
Standard Deviation 0.08
|
0.02 ratio
Standard Deviation 0.09
|
0.01 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.01 ratio
Standard Deviation 0.11
|
0.00 ratio
Standard Deviation 0.05
|
-0.02 ratio
Standard Deviation 0.08
|
0.03 ratio
Standard Deviation 0.12
|
0.01 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.06 mmol/l
Standard Deviation 0.37
|
-0.01 mmol/l
Standard Deviation 0.16
|
0.08 mmol/l
Standard Deviation 0.19
|
-0.02 mmol/l
Standard Deviation 0.24
|
-0.08 mmol/l
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
|
-0.47 mmol/l
Standard Deviation 0.54
|
0.14 mmol/l
Standard Deviation 0.28
|
0.09 mmol/l
Standard Deviation 0.55
|
0.09 mmol/l
Standard Deviation 0.66
|
-0.12 mmol/l
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=9 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
|
-0.16 mmol/l
Standard Deviation 0.56
|
0.12 mmol/l
Standard Deviation 0.26
|
0.16 mmol/l
Standard Deviation 0.34
|
0.05 mmol/l
Standard Deviation 0.59
|
-0.03 mmol/l
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
|
-2.86 umol/l
Standard Deviation 8.84
|
-3.51 umol/l
Standard Deviation 10.88
|
-4.92 umol/l
Standard Deviation 6.04
|
0.64 umol/l
Standard Deviation 11.32
|
-3.41 umol/l
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
|
-0.19 umol/l
Standard Deviation 0.84
|
0.18 umol/l
Standard Deviation 0.51
|
0.11 umol/l
Standard Deviation 0.53
|
0.08 umol/l
Standard Deviation 0.66
|
0.16 umol/l
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
|
-0.01 ratio
Standard Deviation 0.23
|
0.07 ratio
Standard Deviation 0.15
|
0.08 ratio
Standard Deviation 0.13
|
0.01 ratio
Standard Deviation 0.14
|
0.07 ratio
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
|
0.06 mmol/l
Standard Deviation 0.17
|
-0.03 mmol/l
Standard Deviation 0.23
|
-0.05 mmol/l
Standard Deviation 0.30
|
-0.02 mmol/l
Standard Deviation 0.18
|
0.01 mmol/l
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
|
-0.23 mmol/l
Standard Deviation 2.02
|
0.44 mmol/l
Standard Deviation 2.00
|
0.41 mmol/l
Standard Deviation 0.82
|
-0.76 mmol/l
Standard Deviation 1.00
|
0.38 mmol/l
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=10 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
|
2.8 umol/l
Standard Deviation 42.06
|
14.5 umol/l
Standard Deviation 29.53
|
-2.6 umol/l
Standard Deviation 20.41
|
1.1 umol/l
Standard Deviation 11.68
|
9.5 umol/l
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
|
0.14 percent
Standard Deviation 1.41
|
0.16 percent
Standard Deviation 0.44
|
0.08 percent
Standard Deviation 0.44
|
-0.03 percent
Standard Deviation 0.22
|
0.31 percent
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=6 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=10 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=12 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
|
-0.07 mmol/l
Standard Deviation 1.89
|
1.09 mmol/l
Standard Deviation 3.81
|
-0.78 mmol/l
Standard Deviation 1.51
|
0.22 mmol/l
Standard Deviation 1.85
|
0.42 mmol/l
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=9 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=12 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
|
80.9 pmol/l
Standard Deviation 223.91
|
-156.6 pmol/l
Standard Deviation 358.53
|
-193.5 pmol/l
Standard Deviation 232.17
|
83.5 pmol/l
Standard Deviation 427.94
|
-40.8 pmol/l
Standard Deviation 475.88
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
|
12.01 pmol/l
Standard Deviation 56.22
|
-6.06 pmol/l
Standard Deviation 104.78
|
13.44 pmol/l
Standard Deviation 49.03
|
45.62 pmol/l
Standard Deviation 183.92
|
2.79 pmol/l
Standard Deviation 61.44
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=12 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
|
0.02 nmol/l
Standard Deviation 0.15
|
0.09 nmol/l
Standard Deviation 0.28
|
-0.03 nmol/l
Standard Deviation 0.18
|
0.12 nmol/l
Standard Deviation 0.31
|
0.09 nmol/l
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
|
0.19 IR score
Standard Deviation 1.00
|
-0.19 IR score
Standard Deviation 2.54
|
0.35 IR score
Standard Deviation 1.20
|
0.64 IR score
Standard Deviation 3.15
|
0.09 IR score
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
|
-5.26 percent sensitivity
Standard Deviation 8.62
|
-1.71 percent sensitivity
Standard Deviation 12.62
|
1.71 percent sensitivity
Standard Deviation 26.48
|
6.47 percent sensitivity
Standard Deviation 27.00
|
-4.07 percent sensitivity
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=9 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
|
8.13 percent beta function
Standard Deviation 23.56
|
-7.64 percent beta function
Standard Deviation 35.00
|
-1.31 percent beta function
Standard Deviation 19.06
|
36.59 percent beta function
Standard Deviation 70.55
|
-2.41 percent beta function
Standard Deviation 19.96
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment
|
-0.38 kg/m^2
Standard Deviation 0.65
|
-0.02 kg/m^2
Standard Deviation 0.72
|
-0.20 kg/m^2
Standard Deviation 1.16
|
-0.21 kg/m^2
Standard Deviation 1.09
|
-0.50 kg/m^2
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment
|
-0.00 ratio
Standard Deviation 0.06
|
-0.00 ratio
Standard Deviation 0.04
|
0.00 ratio
Standard Deviation 0.03
|
-0.00 ratio
Standard Deviation 0.02
|
-0.01 ratio
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment
|
-1.05 kg
Standard Deviation 1.88
|
-0.10 kg
Standard Deviation 2.07
|
-0.46 kg
Standard Deviation 3.40
|
-0.66 kg
Standard Deviation 3.09
|
-1.64 kg
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment
|
0.82 cm
Standard Deviation 3.90
|
-0.17 cm
Standard Deviation 2.59
|
0.31 cm
Standard Deviation 4.31
|
-0.39 cm
Standard Deviation 1.48
|
-0.86 cm
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment
|
1.12 cm
Standard Deviation 4.93
|
0.07 cm
Standard Deviation 2.54
|
0.38 cm
Standard Deviation 3.48
|
-0.19 cm
Standard Deviation 1.30
|
-0.20 cm
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=12 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
0.10 litres
Standard Deviation 0.96
|
0.62 litres
Standard Deviation 1.02
|
0.42 litres
Standard Deviation 0.87
|
-0.11 litres
Standard Deviation 0.78
|
0.27 litres
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=12 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
-0.3 litres
Standard Deviation 1.05
|
0.5 litres
Standard Deviation 0.56
|
-0.0 litres
Standard Deviation 0.66
|
0.1 litres
Standard Deviation 0.84
|
0.3 litres
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=12 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
-0.23 litres
Standard Deviation 1.53
|
1.08 litres
Standard Deviation 1.42
|
0.37 litres
Standard Deviation 1.25
|
-0.05 litres
Standard Deviation 1.52
|
0.59 litres
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
-0.22 litres
Standard Deviation 1.13
|
-0.75 litres
Standard Deviation 0.87
|
0.02 litres
Standard Deviation 0.62
|
-0.29 litres
Standard Deviation 0.75
|
-0.37 litres
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
0.6 litres
Standard Deviation 2.98
|
0.4 litres
Standard Deviation 1.35
|
0.2 litres
Standard Deviation 1.37
|
0.8 litres
Standard Deviation 3.17
|
-2.4 litres
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
|
0.33 litres
Standard Deviation 3.81
|
-0.36 litres
Standard Deviation 1.52
|
0.18 litres
Standard Deviation 1.99
|
0.56 litres
Standard Deviation 3.87
|
-2.81 litres
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment
|
-0.09 litres
Standard Deviation 2.13
|
0.46 litres
Standard Deviation 0.56
|
0.40 litres
Standard Deviation 1.07
|
-0.52 litres
Standard Deviation 1.29
|
-0.88 litres
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment
|
0.22 litres
Standard Deviation 2.63
|
1.11 litres
Standard Deviation 0.78
|
0.01 litres
Standard Deviation 1.88
|
1.08 litres
Standard Deviation 3.26
|
-2.44 litres
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment
|
0.13 litres
Standard Deviation 4.61
|
1.57 litres
Standard Deviation 0.46
|
0.40 litres
Standard Deviation 2.65
|
0.57 litres
Standard Deviation 4.34
|
-3.31 litres
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=7 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=4 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=6 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=6 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=7 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment
|
-0.02 litres
Standard Deviation 0.08
|
0.05 litres
Standard Deviation 0.06
|
-0.01 litres
Standard Deviation 0.06
|
0.01 litres
Standard Deviation 0.08
|
0.04 litres
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=11 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment
|
-1.12 percent liver fat
Standard Deviation 19.75
|
0.37 percent liver fat
Standard Deviation 7.15
|
-4.73 percent liver fat
Standard Deviation 9.87
|
0.77 percent liver fat
Standard Deviation 10.56
|
-2.95 percent liver fat
Standard Deviation 12.40
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=10 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=11 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment
|
-1.19 units on a scale
Standard Deviation 2.02
|
-0.84 units on a scale
Standard Deviation 1.96
|
-0.69 units on a scale
Standard Deviation 0.99
|
-0.36 units on a scale
Standard Deviation 2.01
|
-0.59 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Day 1 - Day 92Population: All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.
The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
Adverse Events as a Measure of Patient Safety
|
7 participants
|
8 participants
|
11 participants
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and the End of Treatment (Day 92)Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.
Outcome measures
| Measure |
1:1 GWP42003 : GWP42004
n=11 Participants
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=11 Participants
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 Participants
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 Participants
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=13 Participants
Contains excipients only
|
|---|---|---|---|---|---|
|
The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment
|
0.27 units on a scale
Standard Deviation 1.27
|
4.91 units on a scale
Standard Deviation 8.08
|
0.85 units on a scale
Standard Deviation 2.23
|
0.58 units on a scale
Standard Deviation 2.15
|
-0.08 units on a scale
Standard Deviation 4.17
|
Adverse Events
1:1 GWP42003 : GWP42004
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
20:1 GWP42003 : GWP42004
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
GWP42003 and Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
GWP42004 and Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1:1 GWP42003 : GWP42004
n=11 participants at risk
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 participants at risk
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 participants at risk
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 participants at risk
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 participants at risk
Contains excipients only
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • Number of events 1 • All adverse events occurring during the study (up to 133 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
Myocardial infarction
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • Number of events 1 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Self-injurious ideation
|
9.1%
1/11 • Number of events 1 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • Number of events 1 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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 |
1:1 GWP42003 : GWP42004
n=11 participants at risk
Contains 5 mg each of GWP42003 and GWP42004
|
20:1 GWP42003 : GWP42004
n=12 participants at risk
Contains 100 mg GWP42003 and 5 mg GWP42004
|
GWP42003 and Placebo
n=13 participants at risk
Contains 100 mg GWP42003 and placebo (excipients only)
|
GWP42004 and Placebo
n=12 participants at risk
Contains GWP42004 5 mg and placebo (excipients only)
|
Placebo
n=14 participants at risk
Contains excipients only
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Myocardial infarction
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Conjunctival haemorrhage
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Retinal haemorrhage
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Vision blurred
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Visual impairment
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Change of bowel habit
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
16.7%
2/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Flatulence
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Gastrooesophageal reflux disease
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling abnormal
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Irritability
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Vessel puncture site reaction
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Hepatic steatosis
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Ear infection fungal
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Genital candidiasis
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
14.3%
2/14 • All adverse events occurring during the study (up to 133 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
Laryngitis
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
16.7%
2/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Tinea pedis
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Foreign body
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Joint sprain
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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 thyroid stimulating hormone decreased
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Cardiac murmur
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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 increased
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Decreased appetite
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
15.4%
2/13 • All adverse events occurring during the study (up to 133 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.
|
33.3%
4/12 • All adverse events occurring during the study (up to 133 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.
|
14.3%
2/14 • All adverse events occurring during the study (up to 133 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
Diabetes mellitus inadequate control
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Gout
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Hypercholesterolaemia
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Increased appetite
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
16.7%
2/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Arthritis
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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 twitching
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Musculoskeletal pain
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
14.3%
2/14 • All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Carpal tunnel syndrome
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
14.3%
2/14 • All adverse events occurring during the study (up to 133 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
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Lethargy
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Abnormal dreams
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Affect lability
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Sleep disorder
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Haematuria
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
16.7%
2/12 • All adverse events occurring during the study (up to 133 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.
|
14.3%
2/14 • All adverse events occurring during the study (up to 133 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
Hypertonic bladder
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Pollakiuria
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Dry throat
|
9.1%
1/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Dyspnoea
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.1%
1/14 • All adverse events occurring during the study (up to 133 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
Dyspnoea exertional
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Oropharyngeal pain
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Wheezing
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
7.7%
1/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Eczema
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Rosacea
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Skin odour abnormal
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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
Hypertension
|
0.00%
0/11 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/13 • All adverse events occurring during the study (up to 133 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.
|
8.3%
1/12 • All adverse events occurring during the study (up to 133 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.
|
0.00%
0/14 • All adverse events occurring during the study (up to 133 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 Research Ltd.
Phone: 0044 1223266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GW Pharmaceuticals Ltd (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