Trial Outcomes & Findings for A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes (NCT NCT00357370)
NCT ID: NCT00357370
Last Updated: 2017-05-11
Results Overview
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
163 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2017-05-11
Participant Flow
Of 163 participants enrolled, Of these 163 participants, 71 were randomized and received treatment. Of these 71 participants, 60 completed double-blind treatment period
Participant milestones
| Measure |
Dapagliflozin 20 mg
Tablets, oral, once daily for 12 weeks
|
Placebo
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Cohort 1
STARTED
|
4
|
0
|
0
|
|
Cohort 1
COMPLETED
|
4
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
24
|
23
|
24
|
|
Cohort 2
COMPLETED
|
22
|
16
|
22
|
|
Cohort 2
NOT COMPLETED
|
2
|
7
|
2
|
Reasons for withdrawal
| Measure |
Dapagliflozin 20 mg
Tablets, oral, once daily for 12 weeks
|
Placebo
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Cohort 2
Lack of Efficacy
|
0
|
2
|
1
|
|
Cohort 2
Adverse Event
|
1
|
1
|
1
|
|
Cohort 2
Lost to Follow-up
|
0
|
1
|
0
|
|
Cohort 2
non-compliance, not met criteria, etc
|
1
|
1
|
0
|
|
Cohort 2
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin 20 mg
n=24 Participants
Tablets, oral, once daily for 12 weeks
|
Placebo
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 Participants
Tablets, oral, once daily for 12 weeks
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 6.49 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
56.7 Years
STANDARD_DEVIATION 8.92 • n=4 Participants
|
|
Age, Customized
Younger than 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Customized
65 years or older
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Back/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=19 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
|
0.09 % of hemoglobin
Standard Error 0.1406
|
-0.61 % of hemoglobin
Standard Error 0.1276
|
-0.69 % of hemoglobin
Standard Error 0.1278
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=22 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
|
17.80 mg/dL
Standard Error 8.1941
|
2.36 mg/dL
Standard Error 7.9992
|
-9.64 mg/dL
Standard Error 7.9908
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Outcome measures
| Measure |
Placebo
n=19 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
|
1 Participants
5.3
|
3 Participants
13.0
|
1 Participants
4.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
Therapeutic glycemic response is defined as HbA1c \<=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Outcome measures
| Measure |
Placebo
n=19 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
|
0 Participants
5.3
|
1 Participants
13.0
|
0 Participants
4.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
Therapeutic glycemic response is defined as HbA1c decrease from baseline \>= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Outcome measures
| Measure |
Placebo
n=19 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=23 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
|
3 Participants
5.3
|
15 Participants
13.0
|
15 Participants
4.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.
Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=22 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 Participants
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 20 mg
n=24 Participants
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
|
1.69 units/day
Standard Error 2.7659
|
-1.35 units/day
Standard Error 2.6489
|
-0.83 units/day
Standard Error 2.6484
|
Adverse Events
Dapagliflozin 20 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Dapagliflozin 10 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 20 mg
n=24 participants at risk
Tablets, oral, once daily for 12 weeks
|
Placebo
n=23 participants at risk
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 participants at risk
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
General disorders
NON-CARDIAC CHEST PAIN
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.3%
1/23 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Other adverse events
| Measure |
Dapagliflozin 20 mg
n=24 participants at risk
Tablets, oral, once daily for 12 weeks
|
Placebo
n=23 participants at risk
Tablets, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 participants at risk
Tablets, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
3/24 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.3%
1/23 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Renal and urinary disorders
POLLAKIURIA
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
17.4%
4/23 • Number of events 5 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
VOMITING
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Psychiatric disorders
ANXIETY
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.3%
2/24 • Number of events 6 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
General disorders
OEDEMA PERIPHERAL
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
General disorders
FATIGUE
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
INFLUENZA
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.3%
1/23 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
General disorders
THIRST
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.3%
1/23 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.2%
1/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.7%
2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place