Trial Outcomes & Findings for A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone (NCT NCT01095666)
NCT ID: NCT01095666
Last Updated: 2017-09-11
Results Overview
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication 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, 8, 12, 16, 20, and 24 in the double-blind period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1484 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2017-09-11
Participant Flow
Of 1484 patients enrolled, 554 completed a qualification period. Of these 554 patients, 444 were randomized and received treatment. Of these 444 participants, 409 completed the double-blind treatment period
Participant milestones
| Measure |
Placebo + Metformin
|
Dapagliflozin 5 mg + Metformin
|
Dapagliflozin 10 mg + Metformin
|
|---|---|---|---|
|
Overall Study
STARTED
|
145
|
147
|
152
|
|
Overall Study
COMPLETED
|
128
|
136
|
145
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
7
|
Reasons for withdrawal
| Measure |
Placebo + Metformin
|
Dapagliflozin 5 mg + Metformin
|
Dapagliflozin 10 mg + Metformin
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
1
|
|
Overall Study
Non-compliance, not met criteria etc.
|
7
|
2
|
2
|
Baseline Characteristics
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Baseline characteristics by cohort
| Measure |
Placebo + Metformin
n=145 Participants
|
Dapagliflozin 5 mg + Metformin
n=147 Participants
|
Dapagliflozin 10 mg + Metformin
n=152 Participants
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
54.6 Years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
53.8 Years
STANDARD_DEVIATION 9.29 • n=4 Participants
|
|
Age, Customized
Yonger than 65 years
|
129 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
387 Participants
n=4 Participants
|
|
Age, Customized
65 to younger than 75 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Customized
75 years and older
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
59 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
126 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
382 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Korean
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication 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, 8, 12, 16, 20, and 24 in the double-blind period.
Outcome measures
| Measure |
Placebo + Metformin
n=139 Participants
|
Dapagliflozin 5 mg + Metformin
n=146 Participants
|
Dapagliflozin 10 mg + Metformin
n=149 Participants
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
|
-0.23 % of hemoglobin
Standard Error 0.0622
|
-0.82 % of hemoglobin
Standard Error 0.0607
|
-0.85 % of hemoglobin
Standard Error 0.0601
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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, 8, 12, 16, 20, and 24 in the double-blind period.
Outcome measures
| Measure |
Placebo + Metformin
n=140 Participants
|
Dapagliflozin 5 mg + Metformin
n=146 Participants
|
Dapagliflozin 10 mg + Metformin
n=151 Participants
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
|
0.5 mg/dL
Standard Error 2.357
|
-21.6 mg/dL
Standard Error 2.308
|
-26.6 mg/dL
Standard Error 2.269
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing PMG values at baseline and Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. PMG measurements were obtained on Day 1 and week 24 in the double-blind period.
Outcome measures
| Measure |
Placebo + Metformin
n=117 Participants
|
Dapagliflozin 5 mg + Metformin
n=117 Participants
|
Dapagliflozin 10 mg + Metformin
n=124 Participants
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
|
-15.5 mg/dL
Standard Error 4.1548
|
-57.8 mg/dL
Standard Error 4.1547
|
-64.6 mg/dL
Standard Error 4.0357
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.
Outcome measures
| Measure |
Placebo + Metformin
n=141 Participants
|
Dapagliflozin 5 mg + Metformin
n=147 Participants
|
Dapagliflozin 10 mg + Metformin
n=151 Participants
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
|
-0.74 kg
Standard Error 0.1975
|
-1.84 kg
Standard Error 0.1935
|
-2.56 kg
Standard Error 0.1909
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: All randomized participants who received study medication and had nonmissing HbA1C values at Week 24 (LOCF)
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c.
Outcome measures
| Measure |
Placebo + Metformin
n=139 Participants
|
Dapagliflozin 5 mg + Metformin
n=146 Participants
|
Dapagliflozin 10 mg + Metformin
n=149 Participants
|
|---|---|---|---|
|
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
|
17.5 Percentage of Participants
3.136 • Interval 11.3 to 23.6
|
32.9 Percentage of Participants
3.667 • Interval 25.7 to 40.1
|
33.0 Percentage of Participants
3.528 • Interval 26.1 to 39.9
|
Adverse Events
Placebo + Metformin
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Dapagliflozin 5 mg + Metformin
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Dapagliflozin 10 mg + Metformin
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Metformin
n=145 participants at risk
|
Dapagliflozin 5 mg + Metformin
n=147 participants at risk
|
Dapagliflozin 10 mg + Metformin
n=152 participants at risk
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.66%
1/152 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.66%
1/152 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.66%
1/152 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFLAMMATORY PSEUDOTUMOUR
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.68%
1/147 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEIOMYOMA
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.68%
1/147 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Congenital, familial and genetic disorders
MYOCARDIAL BRIDGING
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
PNEUMONIA
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/145 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.68%
1/147 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.69%
1/145 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/147 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/152 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Other adverse events
| Measure |
Placebo + Metformin
n=145 participants at risk
|
Dapagliflozin 5 mg + Metformin
n=147 participants at risk
|
Dapagliflozin 10 mg + Metformin
n=152 participants at risk
|
|---|---|---|---|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
11.0%
16/145 • Number of events 17 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
12.2%
18/147 • Number of events 18 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
11.8%
18/152 • Number of events 19 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.8%
7/145 • Number of events 8 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.1%
6/147 • 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 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
6.6%
10/152 • Number of events 15 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.4%
5/145 • 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 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
6.1%
9/147 • Number of events 9 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.6%
7/152 • Number of events 7 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.1%
3/145 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
9.5%
14/147 • Number of events 16 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
3.9%
6/152 • 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 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
5.5%
8/145 • Number of events 12 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.1%
6/147 • Number of events 7 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
2.0%
3/152 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place