Trial Outcomes & Findings for BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes (NCT NCT01498185)

NCT ID: NCT01498185

Last Updated: 2017-02-10

Results Overview

7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 171 participants
• Primary outcome timeframe: From Baseline to Day 7
• Results posted on: 2017-02-10

Participant Flow

Of 171 participants enrolled, 76 completed a screening period. Of these 76 participants, 70 were randomized and received treatment. Of these 70 participants, 62 completed double-blind treatment period.

Participant milestones

Measure	Placebo + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Overall Study STARTED	13	13	15	14	15
Overall Study COMPLETED	12	12	15	11	12
Overall Study NOT COMPLETED	1	1	0	3	3

Reasons for withdrawal

Measure	Placebo + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Overall Study Adverse Event	0	0	0	1	0
Overall Study Withdrawal by Subject	1	1	0	2	1
Overall Study No longer met criteria, etc	0	0	0	0	2

Baseline Characteristics

BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Placebo + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=15 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin n=15 Participants Tablets, oral, once daily for 2 weeks	Total n=70 Participants Total of all reporting groups
Age, Continuous	34.5 Years STANDARD_DEVIATION 12.18 • n=5 Participants	33.7 Years STANDARD_DEVIATION 9.11 • n=7 Participants	35.7 Years STANDARD_DEVIATION 13.93 • n=5 Participants	34.8 Years STANDARD_DEVIATION 14.00 • n=4 Participants	37.5 Years STANDARD_DEVIATION 15.24 • n=21 Participants	35.3 Years STANDARD_DEVIATION 12.86 • n=8 Participants
Age, Customized Younger than 45 years	10 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	51 Participants n=8 Participants
Age, Customized 45 years and older	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	19 Participants n=8 Participants
Sex/Gender, Customized Male	8 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	40 Participants n=8 Participants
Sex/Gender, Customized Female	5 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	12 Participants n=21 Participants	62 Participants n=8 Participants
Race/Ethnicity, Customized Black/African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: From Baseline to Day 7

Population: All randomized participants who received study medication and had nonmissing values at baseline and Day 7

7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.

Outcome measures

Measure	Placebo + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks
Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7	-16.52 mg/dL Standard Error 14.6316	-19.01 mg/dL Standard Error 10.9920	-17.29 mg/dL Standard Error 7.1451	-23.40 mg/dL Standard Error 9.4334	-17.55 mg/dL Standard Error 10.8430

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)	12.18 ng/mL Geometric Coefficient of Variation 45.93	24.19 ng/mL Geometric Coefficient of Variation 32.46	66.11 ng/mL Geometric Coefficient of Variation 41.07	134.34 ng/mL Geometric Coefficient of Variation 29.33	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)	1.04 hour Full Range 45.93 • Interval 0.4 to 4.0	1.08 hour Full Range 32.46 • Interval 0.2 to 3.0	1.03 hour Full Range 41.07 • Interval 0.5 to 4.0	1.27 hour Full Range 29.33 • Interval 0.0 to 4.0	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as "missing" for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])	48.42 ng*h/mL Geometric Coefficient of Variation 23.71	127.17 ng*h/mL Geometric Coefficient of Variation 32.30	269.09 ng*h/mL Geometric Coefficient of Variation 27.25	600.01 ng*h/mL Geometric Coefficient of Variation 48.33	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)	10.58 ng/mL Geometric Coefficient of Variation 31.73	21.96 ng/mL Geometric Coefficient of Variation 44.48	49.22 ng/mL Geometric Coefficient of Variation 43.33	106.68 ng/mL Geometric Coefficient of Variation 26.80	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)	1.42 hour Full Range 45.93 • Interval 0.9 to 4.0	1.83 hour Full Range 32.46 • Interval 1.0 to 4.0	1.57 hour Full Range 41.07 • Interval 0.8 to 4.0	1.84 hour Full Range 29.33 • Interval 0.5 to 6.0	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as "missing" for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])	49.63 ng*h/mL Geometric Coefficient of Variation 29.85	132.38 ng*h/mL Geometric Coefficient of Variation 36.06	262.58 ng*h/mL Geometric Coefficient of Variation 33.33	567.77 ng*h/mL Geometric Coefficient of Variation 39.59	—

SECONDARY outcome

Timeframe: Day 7 (0 hr to 24 hr post dose)

Population: Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as "missing" for the calculation of PK parameters as well as summary statistics. MR was calculated as the ratio of metabolite to parent AUC(TAU), corrected for molecular weights of dapagliflozin and dapagliflozin 3-O-glucuronide (408.82 and 584.99, respectively).

Outcome measures

Measure	Placebo + Insulin n=12 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=14 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=13 Participants Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]	0.72 (ng*h/mL):(ng*h/mL) Geometric Coefficient of Variation 29.29	0.73 (ng*h/mL):(ng*h/mL) Geometric Coefficient of Variation 33.22	0.68 (ng*h/mL):(ng*h/mL) Geometric Coefficient of Variation 25.69	0.66 (ng*h/mL):(ng*h/mL) Geometric Coefficient of Variation 32.37	—

Adverse Events

Placebo + Insulin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Dapagliflozin 1 mg + Insulin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Dapagliflozin 2.5 mg + Insulin

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Dapagliflozin 5 mg + Insulin

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Dapagliflozin 10 mg + Insulin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo + Insulin n=13 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=13 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=15 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=14 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin n=15 participants at risk Tablets, oral, once daily for 2 weeks
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.

Other adverse events

Measure	Placebo + Insulin n=13 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 1 mg + Insulin n=13 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 2.5 mg + Insulin n=15 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 5 mg + Insulin n=14 participants at risk Tablets, oral, once daily for 2 weeks	Dapagliflozin 10 mg + Insulin n=15 participants at risk Tablets, oral, once daily for 2 weeks
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders DIARRHOEA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders CONSTIPATION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	14.3% 2/14 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders NAUSEA	15.4% 2/13 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders TOOTHACHE	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders VOMITING	7.7% 1/13 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
General disorders PYREXIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
General disorders CATHETER SITE PAIN	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations BED BUG INFESTATION	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations URINARY TRACT INFECTION	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations VAGINAL INFECTION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Musculoskeletal and connective tissue disorders MYALGIA	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Renal and urinary disorders MICTURITION URGENCY	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Renal and urinary disorders DYSURIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Renal and urinary disorders HAEMATURIA	15.4% 2/13 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Cardiac disorders TACHYCARDIA	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Eye disorders EYE IRRITATION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Eye disorders VITREOUS FLOATERS	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Nervous system disorders DIZZINESS	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Nervous system disorders HEADACHE	7.7% 1/13 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	15.4% 2/13 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Nervous system disorders PARAESTHESIA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Psychiatric disorders ABNORMAL DREAMS	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Reproductive system and breast disorders DYSMENORRHOEA	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.1% 1/14 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.7% 1/13 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Vascular disorders FLUSHING	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.7% 1/15 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.

Additional Information

Anna Maria Langkilde

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

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