Trial Outcomes & Findings for Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients (NCT NCT00972244)
NCT ID: NCT00972244
Last Updated: 2013-10-14
Results Overview
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
417 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2013-10-14
Participant Flow
Enrollment: 417; randomized: 279 Study Start Date: August 2009 Study Completion Date: May 2010 Primary Completion Date: May 2010
Participant milestones
| Measure |
1mg Dapagliflozin
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
Dapagliflozin tablet 10 mg once daily
|
Placebo
Placebo Comparator
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
56
|
58
|
52
|
54
|
|
Overall Study
COMPLETED
|
54
|
51
|
56
|
52
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
2
|
0
|
9
|
Reasons for withdrawal
| Measure |
1mg Dapagliflozin
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
Dapagliflozin tablet 10 mg once daily
|
Placebo
Placebo Comparator
|
|---|---|---|---|---|---|
|
Overall Study
Incorrect Enrolment
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Subject No Longer Meets Study Criteria
|
2
|
2
|
0
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
1
|
|
Overall Study
Safety
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Various
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Baseline characteristics by cohort
| Measure |
1mg Dapagliflozin
n=59 Participants
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=56 Participants
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=58 Participants
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=52 Participants
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=54 Participants
Placebo Comparator
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
55.9 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 11.47 • n=4 Participants
|
58.4 years
STANDARD_DEVIATION 9.97 • n=21 Participants
|
57.3 years
STANDARD_DEVIATION 9.98 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
215 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
59 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
279 Participants
n=10 Participants
|
|
HBA1C
|
8.10 percent
STANDARD_DEVIATION 0.785 • n=5 Participants
|
7.92 percent
STANDARD_DEVIATION 0.740 • n=7 Participants
|
8.05 percent
STANDARD_DEVIATION 0.660 • n=5 Participants
|
8.18 percent
STANDARD_DEVIATION 0.690 • n=4 Participants
|
8.12 percent
STANDARD_DEVIATION 0.714 • n=21 Participants
|
8.07 percent
STANDARD_DEVIATION 0.720 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Outcome measures
| Measure |
1mg Dapagliflozin
n=59 Participants
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=54 Participants
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=58 Participants
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=52 Participants
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=52 Participants
Placebo Comparator
|
|---|---|---|---|---|---|
|
Adjusted Mean Change in HbA1c Levels
|
-0.12 percent
Interval -0.25 to 0.01
|
-0.10 percent
Interval -0.24 to 0.04
|
-0.37 percent
Interval -0.5 to -0.23
|
-0.44 percent
Interval -0.58 to -0.29
|
0.35 percent
Interval 0.21 to 0.49
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values
Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Outcome measures
| Measure |
1mg Dapagliflozin
n=50 Participants
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=52 Participants
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=51 Participants
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=47 Participants
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=50 Participants
Placebo Comparator
|
|---|---|---|---|---|---|
|
Adjusted Mean Change in Fasting Plasma Glucose
|
-16.63 mg/dL
Interval -23.25 to -10.0
|
-19.97 mg/dL
Interval -26.47 to -13.47
|
-23.49 mg/dL
Interval -30.06 to -16.93
|
-31.92 mg/dL
Interval -38.76 to -25.09
|
9.45 mg/dL
Interval 2.82 to 16.08
|
SECONDARY outcome
Timeframe: At Week 12Population: Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values
Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy
Outcome measures
| Measure |
1mg Dapagliflozin
n=59 Participants
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=54 Participants
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=58 Participants
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=52 Participants
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=52 Participants
Placebo Comparator
|
|---|---|---|---|---|---|
|
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
|
1.7 Percentage of participants
|
9.3 Percentage of participants
|
5.2 Percentage of participants
|
9.6 Percentage of participants
|
1.9 Percentage of participants
|
Adverse Events
1mg Dapagliflozin
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
2.5mg Dapagliflozin
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
5mg Dapagliflozin
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
10mg Dapagliflozin
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1mg Dapagliflozin
n=59 participants at risk
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=56 participants at risk
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=58 participants at risk
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=52 participants at risk
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=54 participants at risk
Placebo Comparator
|
|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.7%
1/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
General disorders
MULTI-ORGAN FAILURE
|
1.7%
1/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.7%
1/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.9%
1/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
SEPSIS
|
1.7%
1/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
1.7%
1/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.8%
1/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.7%
1/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
Other adverse events
| Measure |
1mg Dapagliflozin
n=59 participants at risk
Dapagliflozin tablet 1 mg once daily
|
2.5mg Dapagliflozin
n=56 participants at risk
Dapagliflozin tablet 2.5 mg once daily
|
5mg Dapagliflozin
n=58 participants at risk
Dapagliflozin tablet 5 mg once daily
|
10mg Dapagliflozin
n=52 participants at risk
Dapagliflozin tablet 10 mg once daily
|
Placebo
n=54 participants at risk
Placebo Comparator
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.1%
3/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
3.4%
2/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.9%
1/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
12/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
17.9%
10/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
12.1%
7/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
23.1%
12/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
24.1%
13/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
5.4%
3/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
3.4%
2/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
1.9%
1/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.7%
1/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
5.2%
3/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/59 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/56 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/58 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
0.00%
0/52 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the study visit was assessed in comparison to the status at study entry.
|
5.6%
3/54 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the 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