Trial Outcomes & Findings for Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (NCT NCT02268214)
NCT ID: NCT02268214
Last Updated: 2018-09-13
Results Overview
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
833 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2018-09-13
Participant Flow
The first subject was enrolled on 11 November 2014. The last subject completed the 24-week short-term treatment period 04 January 2017 and the last subject completed the study 25 August 2017. This study was conducted at 138 sites in 17 countries.
833 participants were randomized to a treatment group. Of the 771 participants not randomized to a treatment group: 585 No longer met study criteria, 125 withdrew consent, 26 were lost to follow-up, and 35 did not continue for other reasons
Participant milestones
| Measure |
Dapagliflozin 5 mg + Insulin
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Overall Study
STARTED
|
277
|
296
|
260
|
|
Overall Study
COMPLETED 24 WEEK PERIOD
|
252
|
273
|
232
|
|
Overall Study
COMPLETED
|
235
|
255
|
218
|
|
Overall Study
NOT COMPLETED
|
42
|
41
|
42
|
Reasons for withdrawal
| Measure |
Dapagliflozin 5 mg + Insulin
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Overall Study
Subject no longer meets study criteria
|
0
|
2
|
0
|
|
Overall Study
Pregnancy
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
11
|
14
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
10
|
|
Overall Study
Subject request to discontinue treatment
|
10
|
8
|
6
|
|
Overall Study
Poor/non-compliance
|
2
|
1
|
2
|
|
Overall Study
Other reasons
|
7
|
3
|
3
|
|
Overall Study
Not entering long-term period
|
2
|
3
|
5
|
Baseline Characteristics
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin 5 mg + Insulin
n=277 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=296 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=260 Participants
Placebo oral tablet once daily + background insulin
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.1 Years
STANDARD_DEVIATION 13.94 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 13.89 • n=7 Participants
|
42.7 Years
STANDARD_DEVIATION 13.57 • n=5 Participants
|
42.7 Years
STANDARD_DEVIATION 13.80 • n=4 Participants
|
|
Age, Customized
< 65 years
|
262 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
787 Participants
n=4 Participants
|
|
Age, Customized
Between 65 and 75 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
430 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=254 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=254 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=257 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Change in HbA1c From Baseline at Week 24
|
-0.45 Percentage of hemoglobin
Standard Error 0.0537
|
-0.47 Percentage of hemoglobin
Standard Error 0.0538
|
-0.03 Percentage of hemoglobin
Standard Error 0.0540
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model\[RMM\])
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=258 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=254 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=258 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
|
-7.74 IU
Standard Error 1.4881
|
-12.16 IU
Standard Error 1.4326
|
1.16 IU
Standard Error 1.6593
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model\[RMM\])
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=259 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=258 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=259 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
|
-3.00 Kg
Standard Error 0.2330
|
-3.67 Kg
Standard Error 0.2299
|
0.05 Kg
Standard Error 0.2407
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model\[RMM\])
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=238 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=239 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=234 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
|
-10.28 mg/dL
Standard Error 1.8862
|
-12.97 mg/dL
Standard Error 1.9231
|
5.06 mg/dL
Standard Error 1.9320
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model\[RMM\])
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=238 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=239 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=234 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
|
-14.92 mg/dL
Standard Error 1.9915
|
-16.55 mg/dL
Standard Error 2.0419
|
2.38 mg/dL
Standard Error 2.0477
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose \> 70 and \<= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model\[RMM\])
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=238 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=239 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=234 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
|
6.98 Percentage
Standard Error 0.8824
|
8.52 Percentage
Standard Error 0.9000
|
-2.13 Percentage
Standard Error 0.9032
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Subjects with HbA1c reduction from baseline to week 24 (LOCF) \>= 0.5% and without severe hypoglycemia events
Outcome measures
| Measure |
Dapagliflozin 5 mg + Insulin
n=256 Participants
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=254 Participants
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=257 Participants
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Responders
|
127 Participants
|
129 Participants
|
65 Participants
|
Adverse Events
Dapagliflozin 5 mg + Insulin
Serious events: 37 serious events
Other events: 123 other events
Deaths: 0 deaths
Dapagliflozin 10 mg + Insulin
Serious events: 40 serious events
Other events: 118 other events
Deaths: 0 deaths
Placebo + Insulin
Serious events: 30 serious events
Other events: 99 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dapagliflozin 5 mg + Insulin
n=277 participants at risk
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=296 participants at risk
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=260 participants at risk
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Eye disorders
Blindness unilateral
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Eye disorders
Cataract
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Eye disorders
Vitreous haemorrhage
|
0.72%
2/277 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
General disorders
Chest pain
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.68%
2/296 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
General disorders
Impaired healing
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
General disorders
Pyrexia
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.36%
1/277 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Chronic sinusitis
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Influenza
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Localised infection
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Pneumonia
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Tooth infection
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/277 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.77%
2/260 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Investigations
Liver function test increased
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.6%
10/277 • Number of events 11 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
2.4%
7/296 • Number of events 7 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.2%
3/260 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.72%
2/277 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.4%
4/296 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.2%
3/260 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.72%
2/277 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.4%
4/296 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.72%
2/277 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.68%
2/296 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Metabolism and nutrition disorders
Obesity
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Multiple sclerosis
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Renal and urinary disorders
Renal colic
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.36%
1/277 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
Embolism
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/296 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.38%
1/260 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/277 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.34%
1/296 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/260 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Other adverse events
| Measure |
Dapagliflozin 5 mg + Insulin
n=277 participants at risk
Dapagliflozin 5 mg oral tablet once daily + background insulin
|
Dapagliflozin 10 mg + Insulin
n=296 participants at risk
Dapagliflozin 10 mg oral tablet once daily + background insulin
|
Placebo + Insulin
n=260 participants at risk
Placebo oral tablet once daily + background insulin
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
11/277 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
7.1%
21/296 • Number of events 25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
3.5%
9/260 • Number of events 10 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
14/277 • Number of events 18 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.1%
15/296 • Number of events 20 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
2.7%
7/260 • Number of events 7 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Gastroenteritis
|
5.4%
15/277 • Number of events 16 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
3.4%
10/296 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
3.1%
8/260 • Number of events 10 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Influenza
|
5.4%
15/277 • Number of events 18 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.1%
15/296 • Number of events 17 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
6.5%
17/260 • Number of events 23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
19/277 • Number of events 26 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
9.5%
28/296 • Number of events 36 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.8%
15/260 • Number of events 28 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
27/277 • Number of events 37 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
3.4%
10/296 • Number of events 12 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
7.3%
19/260 • Number of events 20 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
18.4%
51/277 • Number of events 67 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
15.5%
46/296 • Number of events 65 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
18.5%
48/260 • Number of events 66 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Headache
|
5.1%
14/277 • Number of events 17 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
6.8%
20/296 • Number of events 27 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.0%
13/260 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER