Trial Outcomes & Findings for Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550 (NCT NCT01059864)
NCT ID: NCT01059864
Last Updated: 2012-12-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Baseline (Week 6), Week 12
Results posted on
2012-12-13
Participant Flow
Participant milestones
| Measure |
CP-690,550
Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
|
CP-690,550 + Atorvastatin
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|---|
|
Open-Label Run-In Phase
STARTED
|
111
|
0
|
0
|
|
Open-Label Run-In Phase
COMPLETED
|
98
|
0
|
0
|
|
Open-Label Run-In Phase
NOT COMPLETED
|
13
|
0
|
0
|
|
Double-Blind Treatment Phase
STARTED
|
0
|
50
|
48
|
|
Double-Blind Treatment Phase
Treated
|
0
|
50
|
47
|
|
Double-Blind Treatment Phase
COMPLETED
|
0
|
47
|
45
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
CP-690,550
Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
|
CP-690,550 + Atorvastatin
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|---|
|
Open-Label Run-In Phase
Adverse Event
|
7
|
0
|
0
|
|
Open-Label Run-In Phase
Lack of Efficacy
|
1
|
0
|
0
|
|
Open-Label Run-In Phase
Lost to Follow-up
|
2
|
0
|
0
|
|
Open-Label Run-In Phase
Withdrawal by Subject
|
1
|
0
|
0
|
|
Open-Label Run-In Phase
Protocol Violation
|
2
|
0
|
0
|
|
Double-Blind Treatment Phase
Adverse Event
|
0
|
3
|
3
|
Baseline Characteristics
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Baseline characteristics by cohort
| Measure |
CP-690,550
n=111 Participants
Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
|
|---|---|
|
Age Continuous
|
52.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 6), Week 12Population: Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=46 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=45 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
|
-35.34 percent change
Standard Error 2.25
|
5.80 percent change
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Baseline (Week 6), Week 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=46 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=45 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
|
-51.49 milligram per deciliter (mg/dL)
Standard Error 2.99
|
5.30 milligram per deciliter (mg/dL)
Standard Error 3.02
|
SECONDARY outcome
Timeframe: Day 0, Week 2, 6 (Baseline), 10, 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
12-Hours Fasting Lipid Profile
Week 2: Total Cholesterol
|
213.11 mg/dL
Standard Deviation 43.02
|
222.85 mg/dL
Standard Deviation 40.50
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): Total Cholesterol
|
228.22 mg/dL
Standard Deviation 47.93
|
234.27 mg/dL
Standard Deviation 43.99
|
|
12-Hours Fasting Lipid Profile
Day 0: LDL-C
|
111.99 mg/dL
Standard Deviation 30.21
|
114.68 mg/dL
Standard Deviation 30.54
|
|
12-Hours Fasting Lipid Profile
Week 2: LDL-C
|
124.87 mg/dL
Standard Deviation 30.97
|
132.94 mg/dL
Standard Deviation 34.90
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): LDL-C
|
135.83 mg/dL
Standard Deviation 39.39
|
138.26 mg/dL
Standard Deviation 39.07
|
|
12-Hours Fasting Lipid Profile
Week 10: LDL-C
|
80.58 mg/dL
Standard Deviation 24.45
|
141.52 mg/dL
Standard Deviation 35.17
|
|
12-Hours Fasting Lipid Profile
Week 12: LDL-C
|
84.03 mg/dL
Standard Deviation 21.94
|
142.61 mg/dL
Standard Deviation 35.72
|
|
12-Hours Fasting Lipid Profile
Day 0: HDL-C
|
54.96 mg/dL
Standard Deviation 14.96
|
56.20 mg/dL
Standard Deviation 14.18
|
|
12-Hours Fasting Lipid Profile
Week 2: HDL-C
|
61.11 mg/dL
Standard Deviation 17.00
|
65.35 mg/dL
Standard Deviation 15.12
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): HDL-C
|
67.39 mg/dL
Standard Deviation 18.35
|
70.58 mg/dL
Standard Deviation 18.00
|
|
12-Hours Fasting Lipid Profile
Week 10: HDL-C
|
70.12 mg/dL
Standard Deviation 19.35
|
70.31 mg/dL
Standard Deviation 18.42
|
|
12-Hours Fasting Lipid Profile
Week 12: HDL-C
|
71.09 mg/dL
Standard Deviation 17.61
|
71.73 mg/dL
Standard Deviation 16.40
|
|
12-Hours Fasting Lipid Profile
Day 0: Total Cholesterol
|
189.62 mg/dL
Standard Deviation 39.26
|
196.58 mg/dL
Standard Deviation 34.41
|
|
12-Hours Fasting Lipid Profile
Week 10: Total Cholesterol
|
174.42 mg/dL
Standard Deviation 32.10
|
238.16 mg/dL
Standard Deviation 40.18
|
|
12-Hours Fasting Lipid Profile
Week 12: Total Cholesterol
|
175.18 mg/dL
Standard Deviation 29.24
|
240.49 mg/dL
Standard Deviation 42.14
|
|
12-Hours Fasting Lipid Profile
Day 0: Apolipoprotein A-1
|
139.48 mg/dL
Standard Deviation 27.70
|
148.36 mg/dL
Standard Deviation 26.25
|
|
12-Hours Fasting Lipid Profile
Week 2: Apolipoprotein A-1
|
153.80 mg/dL
Standard Deviation 31.11
|
168.13 mg/dL
Standard Deviation 24.43
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): Apolipoprotein A-1
|
164.18 mg/dL
Standard Deviation 29.76
|
171.81 mg/dL
Standard Deviation 28.02
|
|
12-Hours Fasting Lipid Profile
Week 10: Apolipoprotein A-1
|
171.87 mg/dL
Standard Deviation 30.47
|
172.30 mg/dL
Standard Deviation 29.00
|
|
12-Hours Fasting Lipid Profile
Week 12: Apolipoprotein A-1
|
171.02 mg/dL
Standard Deviation 30.93
|
178.36 mg/dL
Standard Deviation 28.55
|
|
12-Hours Fasting Lipid Profile
Day 0: Apolipoprotein B
|
90.30 mg/dL
Standard Deviation 21.89
|
94.09 mg/dL
Standard Deviation 20.04
|
|
12-Hours Fasting Lipid Profile
Week 2: Apolipoprotein B
|
96.18 mg/dL
Standard Deviation 23.35
|
101.74 mg/dL
Standard Deviation 22.78
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): Apolipoprotein B
|
100.28 mg/dL
Standard Deviation 26.64
|
100.38 mg/dL
Standard Deviation 22.05
|
|
12-Hours Fasting Lipid Profile
Week 10: Apolipoprotein B
|
69.32 mg/dL
Standard Deviation 20.33
|
103.96 mg/dL
Standard Deviation 23.63
|
|
12-Hours Fasting Lipid Profile
Week 12: Apolipoprotein B
|
70.35 mg/dL
Standard Deviation 15.06
|
105.84 mg/dL
Standard Deviation 23.48
|
|
12-Hours Fasting Lipid Profile
Day 0: TGs
|
113.54 mg/dL
Standard Deviation 52.17
|
128.76 mg/dL
Standard Deviation 69.17
|
|
12-Hours Fasting Lipid Profile
Week 2: TGs
|
135.69 mg/dL
Standard Deviation 76.80
|
123.18 mg/dL
Standard Deviation 62.51
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): TGs
|
127.16 mg/dL
Standard Deviation 77.16
|
127.63 mg/dL
Standard Deviation 58.48
|
|
12-Hours Fasting Lipid Profile
Week 10: TGs
|
117.90 mg/dL
Standard Deviation 78.04
|
133.63 mg/dL
Standard Deviation 84.23
|
|
12-Hours Fasting Lipid Profile
Week 12: TGs
|
100.78 mg/dL
Standard Deviation 35.87
|
131.48 mg/dL
Standard Deviation 56.66
|
|
12-Hours Fasting Lipid Profile
Day 0: VLDL-C
|
57.73 mg/dL
Standard Deviation 49.23
|
70.41 mg/dL
Standard Deviation 68.55
|
|
12-Hours Fasting Lipid Profile
Week 2: VLDL-C
|
81.48 mg/dL
Standard Deviation 73.57
|
74.89 mg/dL
Standard Deviation 65.42
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): VLDL-C
|
76.10 mg/dL
Standard Deviation 71.63
|
75.30 mg/dL
Standard Deviation 58.91
|
|
12-Hours Fasting Lipid Profile
Week 10: VLDL-C
|
69.00 mg/dL
Standard Deviation 75.49
|
79.43 mg/dL
Standard Deviation 66.86
|
|
12-Hours Fasting Lipid Profile
Week 12: VLDL-C
|
51.59 mg/dL
Standard Deviation 33.38
|
78.64 mg/dL
Standard Deviation 53.10
|
|
12-Hours Fasting Lipid Profile
Day 0: Non-HDL-C
|
134.66 mg/dL
Standard Deviation 35.32
|
140.39 mg/dL
Standard Deviation 33.75
|
|
12-Hours Fasting Lipid Profile
Week 2: Non-HDL-C
|
152.00 mg/dL
Standard Deviation 39.84
|
157.50 mg/dL
Standard Deviation 39.61
|
|
12-Hours Fasting Lipid Profile
Week 6 (Baseline): Non-HDL-C
|
160.83 mg/dL
Standard Deviation 47.50
|
163.69 mg/dL
Standard Deviation 41.96
|
|
12-Hours Fasting Lipid Profile
Week 10: Non-HDL-C
|
104.30 mg/dL
Standard Deviation 32.65
|
167.85 mg/dL
Standard Deviation 40.22
|
|
12-Hours Fasting Lipid Profile
Week 12: Non-HDL-C
|
104.09 mg/dL
Standard Deviation 25.49
|
168.76 mg/dL
Standard Deviation 39.90
|
SECONDARY outcome
Timeframe: Day 0, Week 2, 6 (Baseline), 10, 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Day 0: VLDL-C Particles
|
42.08 nanometer (nm)
Standard Deviation 6.68
|
46.15 nanometer (nm)
Standard Deviation 10.12
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 2: VLDL-C Particles
|
47.41 nanometer (nm)
Standard Deviation 11.86
|
47.31 nanometer (nm)
Standard Deviation 8.28
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 6 (Baseline): VLDL-C Particles
|
44.75 nanometer (nm)
Standard Deviation 6.41
|
48.67 nanometer (nm)
Standard Deviation 9.09
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 10: VLDL-C Particles
|
48.29 nanometer (nm)
Standard Deviation 8.65
|
47.48 nanometer (nm)
Standard Deviation 7.34
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 12: VLDL-C Particles
|
47.35 nanometer (nm)
Standard Deviation 7.40
|
47.58 nanometer (nm)
Standard Deviation 8.18
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Day 0: LDL-C Particles
|
21.19 nanometer (nm)
Standard Deviation 0.90
|
21.14 nanometer (nm)
Standard Deviation 0.74
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 2: LDL-C Particles
|
21.44 nanometer (nm)
Standard Deviation 0.77
|
21.55 nanometer (nm)
Standard Deviation 0.79
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 6 (Baseline): LDL-C Particles
|
21.65 nanometer (nm)
Standard Deviation 0.92
|
21.66 nanometer (nm)
Standard Deviation 0.81
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 10: LDL-C Particles
|
21.67 nanometer (nm)
Standard Deviation 0.86
|
21.45 nanometer (nm)
Standard Deviation 0.91
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 12: LDL-C Particles
|
21.74 nanometer (nm)
Standard Deviation 0.80
|
21.51 nanometer (nm)
Standard Deviation 0.80
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Day 0: HDL-C Particles
|
9.29 nanometer (nm)
Standard Deviation 0.44
|
9.21 nanometer (nm)
Standard Deviation 0.48
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 2: HDL-C Particles
|
9.25 nanometer (nm)
Standard Deviation 0.46
|
9.26 nanometer (nm)
Standard Deviation 0.48
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 6 (Baseline): HDL-C Particles
|
9.31 nanometer (nm)
Standard Deviation 0.50
|
9.30 nanometer (nm)
Standard Deviation 0.50
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 10: HDL-C Particles
|
9.33 nanometer (nm)
Standard Deviation 0.47
|
9.22 nanometer (nm)
Standard Deviation 0.53
|
|
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Week 12: HDL-C Particles
|
9.36 nanometer (nm)
Standard Deviation 0.45
|
9.25 nanometer (nm)
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Day 0, Week 2, 6 (Baseline), 10, 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Total LDL-C Particles
|
1154.3 nanomoles per liter (nmol/L)
Standard Deviation 440.45
|
1195.0 nanomoles per liter (nmol/L)
Standard Deviation 352.53
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Total LDL-C Particles
|
787.24 nanomoles per liter (nmol/L)
Standard Deviation 282.87
|
1271.2 nanomoles per liter (nmol/L)
Standard Deviation 381.29
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Medium Small LDL-C Particles
|
104.94 nanomoles per liter (nmol/L)
Standard Deviation 99.40
|
108.19 nanomoles per liter (nmol/L)
Standard Deviation 82.11
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Medium Small LDL-C Particles
|
78.78 nanomoles per liter (nmol/L)
Standard Deviation 64.95
|
130.57 nanomoles per liter (nmol/L)
Standard Deviation 96.04
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Large VLDLCP
|
1.45 nanomoles per liter (nmol/L)
Standard Deviation 1.84
|
2.63 nanomoles per liter (nmol/L)
Standard Deviation 3.48
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Medium VLDL-C Particles
|
22.11 nanomoles per liter (nmol/L)
Standard Deviation 22.14
|
23.26 nanomoles per liter (nmol/L)
Standard Deviation 24.79
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Medium VLDL-C Particles
|
27.20 nanomoles per liter (nmol/L)
Standard Deviation 25.39
|
25.75 nanomoles per liter (nmol/L)
Standard Deviation 27.62
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Medium VLDL-C Particles
|
26.54 nanomoles per liter (nmol/L)
Standard Deviation 23.72
|
24.59 nanomoles per liter (nmol/L)
Standard Deviation 22.43
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Medium VLDL-C Particles
|
25.36 nanomoles per liter (nmol/L)
Standard Deviation 28.17
|
25.27 nanomoles per liter (nmol/L)
Standard Deviation 21.74
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Medium VLDL-C Particles
|
20.67 nanomoles per liter (nmol/L)
Standard Deviation 12.95
|
25.46 nanomoles per liter (nmol/L)
Standard Deviation 20.40
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Small VLDL-C Particles
|
37.64 nanomoles per liter (nmol/L)
Standard Deviation 19.93
|
30.15 nanomoles per liter (nmol/L)
Standard Deviation 19.02
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Small VLDL-C Particles
|
38.61 nanomoles per liter (nmol/L)
Standard Deviation 20.27
|
36.98 nanomoles per liter (nmol/L)
Standard Deviation 21.89
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Small VLDL-C Particles
|
44.26 nanomoles per liter (nmol/L)
Standard Deviation 27.94
|
38.39 nanomoles per liter (nmol/L)
Standard Deviation 21.85
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Small VLDL-C Particles
|
25.38 nanomoles per liter (nmol/L)
Standard Deviation 18.80
|
41.94 nanomoles per liter (nmol/L)
Standard Deviation 23.77
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Small VLDL-C Particles
|
22.94 nanomoles per liter (nmol/L)
Standard Deviation 17.39
|
44.01 nanomoles per liter (nmol/L)
Standard Deviation 23.51
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Total LDL-C Particles
|
1111.8 nanomoles per liter (nmol/L)
Standard Deviation 336.45
|
1222.2 nanomoles per liter (nmol/L)
Standard Deviation 350.51
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Total LDL-C Particles
|
1175.9 nanomoles per liter (nmol/L)
Standard Deviation 365.28
|
1201.7 nanomoles per liter (nmol/L)
Standard Deviation 342.82
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Total LDL-C Particles
|
801.39 nanomoles per liter (nmol/L)
Standard Deviation 285.35
|
1264.9 nanomoles per liter (nmol/L)
Standard Deviation 410.30
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: IDL Particles
|
27.12 nanomoles per liter (nmol/L)
Standard Deviation 31.90
|
30.98 nanomoles per liter (nmol/L)
Standard Deviation 37.49
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: IDL Particles
|
36.58 nanomoles per liter (nmol/L)
Standard Deviation 42.24
|
55.74 nanomoles per liter (nmol/L)
Standard Deviation 55.78
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): IDL Particles
|
43.37 nanomoles per liter (nmol/L)
Standard Deviation 52.14
|
53.94 nanomoles per liter (nmol/L)
Standard Deviation 51.70
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: IDL Particles
|
24.46 nanomoles per liter (nmol/L)
Standard Deviation 38.14
|
69.78 nanomoles per liter (nmol/L)
Standard Deviation 74.08
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: IDL Particles
|
22.22 nanomoles per liter (nmol/L)
Standard Deviation 39.47
|
66.91 nanomoles per liter (nmol/L)
Standard Deviation 62.54
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Large LDL-C Particles
|
451.88 nanomoles per liter (nmol/L)
Standard Deviation 247.55
|
468.67 nanomoles per liter (nmol/L)
Standard Deviation 191.87
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Large LDL-C Particles
|
543.28 nanomoles per liter (nmol/L)
Standard Deviation 225.96
|
589.28 nanomoles per liter (nmol/L)
Standard Deviation 243.27
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Large LDL-C Particles
|
581.73 nanomoles per liter (nmol/L)
Standard Deviation 239.90
|
631.55 nanomoles per liter (nmol/L)
Standard Deviation 266.98
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Large LDL-C Particles
|
400.11 nanomoles per liter (nmol/L)
Standard Deviation 175.75
|
582.04 nanomoles per liter (nmol/L)
Standard Deviation 268.41
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Large LDL-C Particles
|
424.26 nanomoles per liter (nmol/L)
Standard Deviation 161.19
|
598.34 nanomoles per liter (nmol/L)
Standard Deviation 241.53
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Total Small LDL-C Particles
|
632.73 nanomoles per liter (nmol/L)
Standard Deviation 401.86
|
722.46 nanomoles per liter (nmol/L)
Standard Deviation 373.82
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Total Small LDL-C Particles
|
596.12 nanomoles per liter (nmol/L)
Standard Deviation 415.78
|
556.67 nanomoles per liter (nmol/L)
Standard Deviation 399.91
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Total Small LDL-C Particles
|
528.94 nanomoles per liter (nmol/L)
Standard Deviation 501.32
|
509.45 nanomoles per liter (nmol/L)
Standard Deviation 385.73
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Total Small LDL-C Particles
|
362.72 nanomoles per liter (nmol/L)
Standard Deviation 309.76
|
619.43 nanomoles per liter (nmol/L)
Standard Deviation 445.00
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Total Small LDL-C Particles
|
354.96 nanomoles per liter (nmol/L)
Standard Deviation 313.20
|
599.77 nanomoles per liter (nmol/L)
Standard Deviation 456.21
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Medium Small LDL-C Particles
|
127.08 nanomoles per liter (nmol/L)
Standard Deviation 83.27
|
149.43 nanomoles per liter (nmol/L)
Standard Deviation 78.23
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Medium Small LDL-C Particles
|
117.42 nanomoles per liter (nmol/L)
Standard Deviation 83.36
|
114.74 nanomoles per liter (nmol/L)
Standard Deviation 83.82
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Medium Small LDL-C Particles
|
77.96 nanomoles per liter (nmol/L)
Standard Deviation 66.36
|
124.20 nanomoles per liter (nmol/L)
Standard Deviation 97.98
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Very Small LDL-C Particles
|
505.59 nanomoles per liter (nmol/L)
Standard Deviation 319.41
|
572.98 nanomoles per liter (nmol/L)
Standard Deviation 296.63
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Very Small LDL-C Particles
|
478.62 nanomoles per liter (nmol/L)
Standard Deviation 333.47
|
441.93 nanomoles per liter (nmol/L)
Standard Deviation 317.36
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6 (Baseline): Very Small LDL-C Particles
|
424.02 nanomoles per liter (nmol/L)
Standard Deviation 402.68
|
401.21 nanomoles per liter (nmol/L)
Standard Deviation 305.54
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Very Small LDL-C Particles
|
283.76 nanomoles per liter (nmol/L)
Standard Deviation 246.26
|
489.00 nanomoles per liter (nmol/L)
Standard Deviation 350.20
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Very Small LDL-C Particles
|
276.93 nanomoles per liter (nmol/L)
Standard Deviation 249.02
|
475.55 nanomoles per liter (nmol/L)
Standard Deviation 359.14
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Total VLDLCP
|
61.00 nanomoles per liter (nmol/L)
Standard Deviation 38.88
|
56.20 nanomoles per liter (nmol/L)
Standard Deviation 37.29
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Total VLDLCP
|
68.89 nanomoles per liter (nmol/L)
Standard Deviation 43.74
|
65.24 nanomoles per liter (nmol/L)
Standard Deviation 41.56
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6(Baseline): Total VLDLCP
|
73.23 nanomoles per liter (nmol/L)
Standard Deviation 48.34
|
65.51 nanomoles per liter (nmol/L)
Standard Deviation 41.39
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Total VLDLCP
|
53.22 nanomoles per liter (nmol/L)
Standard Deviation 42.36
|
70.07 nanomoles per liter (nmol/L)
Standard Deviation 43.11
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 12: Total VLDLCP
|
45.07 nanomoles per liter (nmol/L)
Standard Deviation 27.93
|
72.11 nanomoles per liter (nmol/L)
Standard Deviation 37.22
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Day 0: Large VLDLCP
|
1.25 nanomoles per liter (nmol/L)
Standard Deviation 2.14
|
2.79 nanomoles per liter (nmol/L)
Standard Deviation 4.80
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 2: Large VLDLCP
|
3.09 nanomoles per liter (nmol/L)
Standard Deviation 4.58
|
2.50 nanomoles per liter (nmol/L)
Standard Deviation 3.63
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 6(Baseline): Large VLDLCP
|
2.43 nanomoles per liter (nmol/L)
Standard Deviation 4.34
|
2.53 nanomoles per liter (nmol/L)
Standard Deviation 3.63
|
|
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Week 10: Large VLDLCP
|
2.47 nanomoles per liter (nmol/L)
Standard Deviation 4.57
|
2.85 nanomoles per liter (nmol/L)
Standard Deviation 4.66
|
SECONDARY outcome
Timeframe: Day 0, Week 2, 6 (Baseline), 10, 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 2: Medium HDL-C Particles
|
3.87 micromole per liter (mcmol/L)
Standard Deviation 4.31
|
4.43 micromole per liter (mcmol/L)
Standard Deviation 4.41
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 6 (Baseline): Medium HDL-C Particles
|
3.89 micromole per liter (mcmol/L)
Standard Deviation 4.86
|
3.98 micromole per liter (mcmol/L)
Standard Deviation 3.90
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 10: Medium HDL-C Particles
|
4.57 micromole per liter (mcmol/L)
Standard Deviation 5.58
|
4.52 micromole per liter (mcmol/L)
Standard Deviation 4.12
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Day 0: Small HDL-C Particles
|
14.44 micromole per liter (mcmol/L)
Standard Deviation 6.15
|
16.80 micromole per liter (mcmol/L)
Standard Deviation 6.46
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Day 0: Total HDL-C Particles
|
27.08 micromole per liter (mcmol/L)
Standard Deviation 5.74
|
29.58 micromole per liter (mcmol/L)
Standard Deviation 5.97
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 2: Total HDL-C Particles
|
30.89 micromole per liter (mcmol/L)
Standard Deviation 5.81
|
33.68 micromole per liter (mcmol/L)
Standard Deviation 5.74
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 6 (Baseline): Total HDL-C Particles
|
32.90 micromole per liter (mcmol/L)
Standard Deviation 5.94
|
35.44 micromole per liter (mcmol/L)
Standard Deviation 5.99
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 10: Total HDL-C Particles
|
34.57 micromole per liter (mcmol/L)
Standard Deviation 6.03
|
36.07 micromole per liter (mcmol/L)
Standard Deviation 6.89
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 12: Total HDL-C Particles
|
34.20 micromole per liter (mcmol/L)
Standard Deviation 5.63
|
35.77 micromole per liter (mcmol/L)
Standard Deviation 6.26
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Day 0: Large HDL-C Particles
|
8.88 micromole per liter (mcmol/L)
Standard Deviation 3.64
|
8.75 micromole per liter (mcmol/L)
Standard Deviation 4.13
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 2: Large HDL-C Particles
|
9.08 micromole per liter (mcmol/L)
Standard Deviation 4.17
|
9.56 micromole per liter (mcmol/L)
Standard Deviation 4.34
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 6 (Baseline): Large HDL-C Particles
|
10.04 micromole per liter (mcmol/L)
Standard Deviation 4.67
|
10.63 micromole per liter (mcmol/L)
Standard Deviation 4.69
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 10: Large HDL-C Particles
|
10.98 micromole per liter (mcmol/L)
Standard Deviation 4.39
|
9.93 micromole per liter (mcmol/L)
Standard Deviation 4.81
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 12: Large HDL-C Particles
|
11.23 micromole per liter (mcmol/L)
Standard Deviation 4.43
|
10.23 micromole per liter (mcmol/L)
Standard Deviation 4.34
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Day 0: Medium HDL-C Particles
|
3.74 micromole per liter (mcmol/L)
Standard Deviation 3.94
|
4.01 micromole per liter (mcmol/L)
Standard Deviation 3.63
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 12: Medium HDL-C Particles
|
3.85 micromole per liter (mcmol/L)
Standard Deviation 3.97
|
4.74 micromole per liter (mcmol/L)
Standard Deviation 4.59
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 2: Small HDL-C Particles
|
17.94 micromole per liter (mcmol/L)
Standard Deviation 6.27
|
19.70 micromole per liter (mcmol/L)
Standard Deviation 6.83
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 6 (Baseline): Small HDL-C Particles
|
18.97 micromole per liter (mcmol/L)
Standard Deviation 6.35
|
20.83 micromole per liter (mcmol/L)
Standard Deviation 6.95
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 10: Small HDL-C Particles
|
19.04 micromole per liter (mcmol/L)
Standard Deviation 7.30
|
21.63 micromole per liter (mcmol/L)
Standard Deviation 6.17
|
|
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Week 12: Small HDL-C Particles
|
19.15 micromole per liter (mcmol/L)
Standard Deviation 6.19
|
20.79 micromole per liter (mcmol/L)
Standard Deviation 7.10
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter \[mg/L\]). DAS28-3 (CRP) less than or equal to (\<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (\>) 3.2 to 5.1 indicated moderate to high disease activity.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 6 (Baseline)
|
3.44 units on a scale
Standard Deviation 1.28
|
3.33 units on a scale
Standard Deviation 1.10
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Day 0
|
5.38 units on a scale
Standard Deviation 1.24
|
5.23 units on a scale
Standard Deviation 1.00
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 12
|
3.06 units on a scale
Standard Deviation 1.26
|
2.99 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.
DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) \[mg/L\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 \[CRP\] \<=3.2 indicated low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.
DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]). DAS28-3 (ESR) \<=3.2 indicated low disease activity, DAS28-3 (ESR) \>3.2 to 5.1 indicated moderate to high disease activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) \[mm/hr\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) \<=3.2 indicated low disease activity, DAS28-4 (ESR) \>3.2 to 5.1 indicated moderate to high disease activity.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=46 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Week 6 (Baseline)
|
4.33 units on a scale
Standard Deviation 1.44
|
4.26 units on a scale
Standard Deviation 1.15
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Week 12
|
3.84 units on a scale
Standard Deviation 1.57
|
3.81 units on a scale
Standard Deviation 1.29
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Day 0
|
6.60 units on a scale
Standard Deviation 1.32
|
6.44 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 6 (Baseline)
|
76.0 percentage of participants
|
76.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 12
|
82.6 percentage of participants
|
65.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 6 (Baseline)
|
48.0 percentage of participants
|
42.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 12
|
67.4 percentage of participants
|
45.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 6 (Baseline)
|
20.0 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 12
|
34.8 percentage of participants
|
30.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Tender-Joint Count
Day 0
|
23.20 tender joints
Standard Deviation 18.15
|
21.38 tender joints
Standard Deviation 14.80
|
|
Tender-Joint Count
Week 6 (Baseline)
|
10.48 tender joints
Standard Deviation 12.56
|
10.99 tender joints
Standard Deviation 13.22
|
|
Tender-Joint Count
Week 12
|
8.57 tender joints
Standard Deviation 12.83
|
7.83 tender joints
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), Week 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Swollen-Joint Count
Day 0
|
16.90 swollen joints
Standard Deviation 12.67
|
15.34 swollen joints
Standard Deviation 11.34
|
|
Swollen-Joint Count
Week 6 (Baseline)
|
6.36 swollen joints
Standard Deviation 7.08
|
5.68 swollen joints
Standard Deviation 5.94
|
|
Swollen-Joint Count
Week 12
|
4.85 swollen joints
Standard Deviation 5.51
|
5.15 swollen joints
Standard Deviation 6.04
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
C-Reactive Protein (CRP)
Day 0
|
33.17 mg/L
Standard Deviation 38.22
|
22.25 mg/L
Standard Deviation 26.96
|
|
C-Reactive Protein (CRP)
Week 6 (Baseline)
|
6.31 mg/L
Standard Deviation 11.76
|
3.34 mg/L
Standard Deviation 5.11
|
|
C-Reactive Protein (CRP)
Week 12
|
6.04 mg/L
Standard Deviation 12.23
|
3.32 mg/L
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Day 0
|
69.76 mm/hr
Standard Deviation 36.40
|
60.32 mm/hr
Standard Deviation 33.96
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 6 (Baseline)
|
37.42 mm/hr
Standard Deviation 28.81
|
29.98 mm/hr
Standard Deviation 20.46
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 12
|
34.43 mm/hr
Standard Deviation 27.02
|
30.31 mm/hr
Standard Deviation 20.72
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Patient Assessment of Arthritis Pain
Day 0
|
65.66 mm
Standard Deviation 20.13
|
64.41 mm
Standard Deviation 27.40
|
|
Patient Assessment of Arthritis Pain
Week 6 (Baseline)
|
30.18 mm
Standard Deviation 21.91
|
31.26 mm
Standard Deviation 25.68
|
|
Patient Assessment of Arthritis Pain
Week 12
|
25.72 mm
Standard Deviation 21.33
|
29.09 mm
Standard Deviation 25.11
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), Week 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient's global assessment of arthritis. Physician's response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Physician's Global Assessment (PhysGA) of Arthritis Pain
Week 12
|
24.30 mm
Standard Deviation 21.02
|
29.70 mm
Standard Deviation 25.17
|
|
Physician's Global Assessment (PhysGA) of Arthritis Pain
Day 0
|
63.28 mm
Standard Deviation 20.18
|
65.38 mm
Standard Deviation 24.86
|
|
Physician's Global Assessment (PhysGA) of Arthritis Pain
Week 6 (Baseline)
|
30.80 mm
Standard Deviation 22.09
|
31.85 mm
Standard Deviation 26.12
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), Week 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Patient's Global Assessment (PtGA) of Arthritis Pain
Day 0
|
68.10 mm
Standard Deviation 17.17
|
61.67 mm
Standard Deviation 18.72
|
|
Patient's Global Assessment (PtGA) of Arthritis Pain
Week 6 (Baseline)
|
27.66 mm
Standard Deviation 18.03
|
28.08 mm
Standard Deviation 16.52
|
|
Patient's Global Assessment (PtGA) of Arthritis Pain
Week 12
|
23.33 mm
Standard Deviation 20.15
|
24.15 mm
Standard Deviation 15.91
|
SECONDARY outcome
Timeframe: Day 0, Week 6 (Baseline), 12Population: FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Outcome measures
| Measure |
CP-690,550 + Atorvastatin
n=50 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 Participants
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 6 (Baseline)
|
0.88 units on a scale
Standard Deviation 0.71
|
0.88 units on a scale
Standard Deviation 0.72
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 12
|
0.74 units on a scale
Standard Deviation 0.69
|
0.92 units on a scale
Standard Deviation 0.78
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Day 0
|
1.54 units on a scale
Standard Deviation 0.74
|
1.46 units on a scale
Standard Deviation 0.74
|
Adverse Events
CP-690,550
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
CP-690,550 + Atorvastatin
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
CP-690,550 + Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550
n=111 participants at risk
Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
|
CP-690,550 + Atorvastatin
n=50 participants at risk
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 participants at risk
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.90%
1/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.90%
1/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CP-690,550
n=111 participants at risk
Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
|
CP-690,550 + Atorvastatin
n=50 participants at risk
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
CP-690,550 + Placebo
n=47 participants at risk
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
|
|---|---|---|---|
|
Infections and infestations
Onychomycosis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
4.5%
5/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular vascular disorder
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
4/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
2.7%
3/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tinel's sign
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER