Trial Outcomes & Findings for Subcutaneous Pharmacokinetics of Belatacept (NCT NCT00569803)
NCT ID: NCT00569803
Last Updated: 2016-09-22
Results Overview
Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
153 participants
Primary outcome timeframe
Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Results posted on
2016-09-22
Participant Flow
153 participants were enrolled, with 106 discontinuing prior to study drug administration because they no longer met study criteria or they withdrew consent. 47 participants met all eligibility criteria and received study medication. 1 subject, who received an incomplete dose due to an injection syringe leak, was replaced.
Participant milestones
| Measure |
Belatacept 50 mg Subcutaneous Injection
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
6
|
5
|
5
|
10
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
5
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Belatacept 50 mg Subcutaneous Injection
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
injection syringe leaked during dosing
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Subcutaneous Pharmacokinetics of Belatacept
Baseline characteristics by cohort
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 11 • n=5 Participants
|
27 years
STANDARD_DEVIATION 12 • n=7 Participants
|
28 years
STANDARD_DEVIATION 12 • n=5 Participants
|
34 years
STANDARD_DEVIATION 18 • n=4 Participants
|
31 years
STANDARD_DEVIATION 11 • n=21 Participants
|
31 years
STANDARD_DEVIATION 10 • n=8 Participants
|
32 years
STANDARD_DEVIATION 16 • n=8 Participants
|
27 years
STANDARD_DEVIATION 6 • n=24 Participants
|
30 years
STANDARD_DEVIATION 12 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Belatacept
|
3.9 ug/mL
Geometric Coefficient of Variation 30
|
6.2 ug/mL
Geometric Coefficient of Variation 34
|
8.5 ug/mL
Geometric Coefficient of Variation 50
|
11.1 ug/mL
Geometric Coefficient of Variation 19
|
14.5 ug/mL
Geometric Coefficient of Variation 16
|
14.5 ug/mL
Geometric Coefficient of Variation 18
|
42.4 ug/mL
Geometric Coefficient of Variation 16
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax) of Belatacept
|
84 hours
Interval 36.0 to 96.0
|
60 hours
Interval 48.0 to 120.0
|
96 hours
Interval 48.0 to 144.0
|
60 hours
Interval 36.0 to 96.0
|
60 hours
Interval 24.0 to 84.0
|
72 hours
Interval 60.0 to 96.0
|
0.5 hours
Interval 0.2 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL).
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
|
2587 ug*h/mL
Interval 2132.0 to 3139.0
|
1848 ug*h/mL
Interval 1523.0 to 2242.0
|
2371 ug*h/mL
Interval 1954.0 to 2876.0
|
2703 ug*h/mL
Interval 2228.0 to 3280.0
|
2650 ug*h/mL
Interval 2184.0 to 3215.0
|
2193 ug*h/mL
Interval 1807.0 to 2660.0
|
3023 ug*h/mL
Interval 2637.0 to 3466.0
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL)
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
|
2639 ug*h/mL
Interval 2172.0 to 3205.0
|
1851 ug*h/mL
Interval 1524.0 to 2248.0
|
2380 ug*h/mL
Interval 1959.0 to 2891.0
|
2719 ug*h/mL
Interval 2238.0 to 3303.0
|
2666 ug*h/mL
Interval 2194.0 to 3238.0
|
2201 ug*h/mL
Interval 1812.0 to 2673.0
|
3031 ug*h/mL
Interval 2642.0 to 3478.0
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Serum Half-life (T-HALF) of Belatacept
|
112 hours
Standard Deviation 25.7
|
100 hours
Standard Deviation 10.1
|
135 hours
Standard Deviation 47.6
|
158 hours
Standard Deviation 46.9
|
161 hours
Standard Deviation 45.3
|
150 hours
Standard Deviation 43.6
|
130 hours
Standard Deviation 27.6
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with SC Belatacept
Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CLT/F) of SC Belatacept
|
47.4 mL/h
Geometric Coefficient of Variation 27
|
67.5 mL/h
Geometric Coefficient of Variation 34
|
52.5 mL/h
Geometric Coefficient of Variation 31
|
46.0 mL/h
Geometric Coefficient of Variation 26
|
46.9 mL/h
Geometric Coefficient of Variation 21
|
56.8 mL/h
Geometric Coefficient of Variation 20
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with IV Belatacept
Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=10 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance (CLT) of IV Belatacept
|
41.2 mL/h
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with IV Belatacept
Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=10 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (VSS) for IV Belatacept
|
7.3 Liters
Standard Deviation 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with SC Belatacept
Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept
|
10.79 Liters
Geometric Coefficient of Variation 31.02
|
15.30 Liters
Geometric Coefficient of Variation 28.79
|
14.12 Liters
Geometric Coefficient of Variation 36.63
|
12.75 Liters
Geometric Coefficient of Variation 14.20
|
13.34 Liters
Geometric Coefficient of Variation 13.77
|
15.82 Liters
Geometric Coefficient of Variation 11.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116Population: All participants treated with Belatacept
AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug\*h/mL). AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration. AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=15 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=15 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
AUC(0-T)
|
898 ug*h/mL
Interval 794.0 to 1017.0
|
1002 ug*h/mL
Interval 885.0 to 1134.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
AUC(INF)
|
906 ug*h/mL
Interval 799.0 to 1027.0
|
1007 ug*h/mL
Interval 888.0 to 1142.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116Population: All treated participants
Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116Population: All treated participants
Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions
mild reaction
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions
moderate reaction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions
severe reaction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 5, 14, 28, 42, 86, 116Population: All treated participants
All clinically significant deviations from normal physical examinations were reported.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1 and 116Population: All treated participants
Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Screening (Day 1)
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Study Discharge (Day 116)
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116Population: All treated participants
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): \<0.85\*Pre-Rx. Hematocrit (%): \<0.85\*Pre-Rx. Platelet Count (\*10\^9 cells per liter:c/L): \<0.85\*LLN or \>1.5\*ULN (if Pre-Rx\<LLN, use \<0.85\*Pre-Rx). Leukocytes (\*10\^3 cells per microliter: c/uL): \<0.9\*LLN, \>1.2\*ULN (if Pre-Rx\<LLN, use \<0.85\*Pre-Rx or \>ULN, if Pre-Rx\>ULN, use \>1.15\*Pre-Rx or \<LLN) Neutrophils+Bands (\*10\^3 c/uL): \<=1.500. Lymphocytes (\*10\^3 c/uL): \<0.750 or \>7.500. Monocytes (\*10\^3 c/uL): \>2.000. Basophils (\*10\^3 c/uL): \>0.400. Eosinophils (\*10\^3 c/uL): \>0.750.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Hemoglobin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Monocytes (absolute)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Eosinophils (absolute)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Hematocrit
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Platelet Count
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Leukocytes
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Neutrophils + Bands (absolute)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Lymphocytes (absolute)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities
Basophils (absolute)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116Population: All treated participants
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): \>1.25\*ULN (if Pre-Rx\>ULN, use \>1.25\*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): \>1.1\*ULN (if Pre-Rx\>ULN, use \>1.25\*Pre-Rx). Blood Urea Nitrogen (mg/dL): \>1.1\*ULN (if Pre-Rx\>ULN, use \>1.2\*Pre-Rx). Creatinine (mg/dL): \>1.33\*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): \<0.95\*LLN, \>1.05\*ULN (if Pre-Rx\<LLN: \<0.95\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.05\*Pre-Rx, \<LLN). Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): \<0.9\*LLN, \>1.1\*ULN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.1\*Pre-Rx, \<LLN). Phosphorus (mg/dL): \<0.85\*LLN, \>1.25\*ULN (if Pre-Rx\<LLN, \<0.85\*Pre-Rx, \>ULN. if Pre-Rx\>ULN: \>1.25\*Pre-Rx, \<LLN).
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Blood Urea Nitrogen
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Creatinine
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Alkaline Phosphatase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Bilirubin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Sodium, Serum
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Potassium, Serum
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Chloride, Serum
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Calcium, Total
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Phosphorus, Inorganic
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Aspartate Aminotransferase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Serum Chemistry Abnormalities
Alanine Aminotransferase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116Population: All treated participants
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose (mg/dL): \<0.8\*LLN, \>1.5\*ULN (if Pre-Rx\<LLN: \<0.8\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>2.0\*Pre-Rx, \<LLN). Protein (grams per deciliter: g/dL): \<0.9\*LLN, \>1.1\*ULN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx, \>ULN. If Pre-Rx\>ULN: \>1.1\*Pre-Rx, \<LLN). Albumin (g/dL): \<0.9\*LLN (if Pre-Rx\<LLN: \<0.9\*Pre-Rx). Uric Acid (mg.dL): \>1.2\*ULN (if Pre-Rx\>ULN: \>1.25\*Pre-Rx). Lactate Dehydrogenase (U/L): \>1.25\*ULN (if Pre-Rx\>ULN: \>1.5\*Pre-Rx)
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
n=6 Participants
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Glucose, Fasting Serum
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Protein, Total
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Uric Acid
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Lactate Dehydrogenase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Albumin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 14, 28, 42, 56, 86, 116Population: All participants treated with Belatacept
The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.
Outcome measures
| Measure |
Belatacept 50 mg Subcutaneous Injection
n=5 Participants
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100 mg Subcutaneous Injection
n=5 Participants
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125 mg Subcutaneous Injection
n=5 Participants
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150 mg Subcutaneous Injections
n=6 Participants
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250 mg Subcutaneous Injections
n=5 Participants
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125 mg Intravenous Infusion
n=10 Participants
125 mg Belatacept intravenous (IV) injection
|
Placebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Immunogenicity to Belatacept
|
4 participants
|
5 participants
|
5 participants
|
5 participants
|
5 participants
|
5 participants
|
10 participants
|
—
|
Adverse Events
Belatacept 50mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Belatacept 100mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Belatacept 125mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Belatacept 150mg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Belatacept 200mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Belatacept 250mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Belatacept 125mg IV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PLACEBO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
All Belatacept
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Belatacept 50mg SC
n=5 participants at risk
Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
|
Belatacept 100mg SC
n=5 participants at risk
Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
|
Belatacept 125mg SC
n=5 participants at risk
Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
|
Belatacept 150mg SC
n=6 participants at risk
Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 200mg SC
n=5 participants at risk
Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 250mg SC
n=5 participants at risk
Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
|
Belatacept 125mg IV
n=10 participants at risk
125 mg Belatacept intravenous (IV) injection
|
PLACEBO
n=6 participants at risk
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
|
All Belatacept
n=41 participants at risk
All participants treated with IV or SC Belatacept of any dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
40.0%
2/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
40.0%
2/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
30.0%
3/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
19.5%
8/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
General disorders
Injection site inflammation
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
16.7%
1/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
General disorders
Mass
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
2/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
9.8%
4/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
16.7%
1/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
16.7%
1/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
30.0%
3/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
19.5%
8/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
2/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
33.3%
2/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
7.3%
3/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
16.7%
1/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
9.8%
4/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
10.0%
1/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
2.4%
1/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
General disorders
Feeling hot
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
33.3%
2/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
2/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
9.8%
4/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
16.7%
1/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
20.0%
1/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/5 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/10 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
0.00%
0/6 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
4.9%
2/41 • From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER