Trial Outcomes & Findings for Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin (NCT NCT01592240)
NCT ID: NCT01592240
Last Updated: 2017-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
354 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2017-12-05
Participant Flow
Participant milestones
| Measure |
Placebo: Every 14 Days
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
PF-04950615 150 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
52
|
50
|
51
|
50
|
51
|
|
Overall Study
COMPLETED
|
47
|
39
|
45
|
47
|
44
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
7
|
3
|
7
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo: Every 14 Days
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
PF-04950615 150 mg: Every 14 Days
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
1
|
0
|
3
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
4
|
1
|
3
|
0
|
2
|
|
Overall Study
Other
|
0
|
3
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Did Not Meet Entrance Criteria
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Baseline characteristics by cohort
| Measure |
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
61.9 Years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
61.4 Years
STANDARD_DEVIATION 9.75 • n=4 Participants
|
58.4 Years
STANDARD_DEVIATION 11.62 • n=21 Participants
|
60.3 Years
STANDARD_DEVIATION 9.64 • n=10 Participants
|
60.2 Years
STANDARD_DEVIATION 8.17 • n=115 Participants
|
60.3 Years
STANDARD_DEVIATION 10.01 • n=6 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
185 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
169 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who were randomized. Here "Overall Number of Participants Analyzed", signifies number of participants those who were evaluable for this outcome measure.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=46 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=46 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=48 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=47 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=44 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=42 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-56.0 milligram per deciliter (mg/dL)
Interval -63.6 to -48.4
|
4.6 milligram per deciliter (mg/dL)
Interval -4.59 to 13.73
|
-23.0 milligram per deciliter (mg/dL)
Interval -32.0 to -14.02
|
-40.3 milligram per deciliter (mg/dL)
Interval -49.09 to -31.48
|
-2.6 milligram per deciliter (mg/dL)
Interval -10.14 to 4.98
|
-36.9 milligram per deciliter (mg/dL)
Interval -44.55 to -29.17
|
-47.6 milligram per deciliter (mg/dL)
Interval -55.45 to -39.85
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set included all participants who were randomized. Here "Overall Number of Participants Analyzed", signifies number of participants those who were evaluable for this outcome measure.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=47 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=43 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=47 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=48 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=47 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=43 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=45 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
|
-44.7 milligram per deciliter
Interval -52.19 to -37.16
|
-0.6 milligram per deciliter
Interval -7.69 to 6.54
|
-24.3 milligram per deciliter
Interval -31.21 to -17.49
|
-30.9 milligram per deciliter
Interval -37.71 to -24.18
|
-3.6 milligram per deciliter
Interval -11.16 to 3.88
|
-32.0 milligram per deciliter
Interval -39.72 to -24.37
|
-46.8 milligram per deciliter
Interval -54.44 to -39.25
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24
Percent Change at Week 12
|
-52.5 percent change
Interval -59.51 to -45.54
|
6.7 percent change
Interval -1.3 to 14.73
|
-20.2 percent change
Interval -28.1 to -12.39
|
-34.4 percent change
Interval -42.11 to -26.72
|
0.6 percent change
Interval -6.34 to 7.54
|
-34.4 percent change
Interval -41.47 to -27.34
|
-41.7 percent change
Interval -48.9 to -34.54
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24
Percent Change at Week 24
|
-40.0 percent change
Interval -46.55 to -33.51
|
2.4 percent change
Interval -4.08 to 8.96
|
-21.3 percent change
Interval -27.63 to -15.07
|
-26.6 percent change
Interval -32.84 to -20.45
|
-0.9 percent change
Interval -7.39 to 5.64
|
-30.0 percent change
Interval -36.64 to -23.29
|
-41.0 percent change
Interval -47.62 to -34.42
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Change at Week 12
|
0.8 milligram per deciliter
Interval -1.28 to 2.92
|
-1.0 milligram per deciliter
Interval -3.33 to 1.27
|
3.4 milligram per deciliter
Interval 1.12 to 5.72
|
2.8 milligram per deciliter
Interval 0.58 to 5.08
|
0.3 milligram per deciliter
Interval -1.8 to 2.39
|
1.9 milligram per deciliter
Interval -0.2 to 4.06
|
2.0 milligram per deciliter
Interval -0.08 to 4.13
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Change at Week 24
|
0.3 milligram per deciliter
Interval -1.6 to 2.28
|
0.2 milligram per deciliter
Interval -2.39 to 2.72
|
2.2 milligram per deciliter
Interval -0.32 to 4.66
|
0.2 milligram per deciliter
Interval -2.28 to 2.6
|
-0.2 milligram per deciliter
Interval -2.09 to 1.79
|
1.6 milligram per deciliter
Interval -0.44 to 3.57
|
0.6 milligram per deciliter
Interval -1.32 to 2.61
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Percent Change at Week 12
|
2.5 percent change
Interval -1.52 to 6.61
|
-0.4 percent change
Interval -4.91 to 4.06
|
7.2 percent change
Interval 2.76 to 11.72
|
6.1 percent change
Interval 1.71 to 10.5
|
1.2 percent change
Interval -2.87 to 5.25
|
4.6 percent change
Interval 0.48 to 8.74
|
3.8 percent change
Interval -0.27 to 7.89
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Percent Change at Week 24
|
2.3 percent change
Interval -1.49 to 6.11
|
1.7 percent change
Interval -2.79 to 6.14
|
4.7 percent change
Interval 0.34 to 8.99
|
1.0 percent change
Interval -3.27 to 5.22
|
-0.3 percent change
Interval -4.07 to 3.55
|
3.6 percent change
Interval -0.27 to 7.55
|
0.6 percent change
Interval -3.26 to 4.43
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Change at Week 12
|
-34.9 milligram per deciliter
Interval -39.77 to -30.04
|
2.3 milligram per deciliter
Interval -3.59 to 8.24
|
-12.2 milligram per deciliter
Interval -18.08 to -6.4
|
-26.2 milligram per deciliter
Interval -31.92 to -20.42
|
-2.8 milligram per deciliter
Interval -7.65 to 2.02
|
-21.4 milligram per deciliter
Interval -26.26 to -16.48
|
-30.5 milligram per deciliter
Interval -35.4 to -25.57
|
|
Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Change at Week 24
|
-27.9 milligram per deciliter
Interval -33.09 to -22.75
|
-2.9 milligram per deciliter
Interval -7.7 to 1.83
|
-15.7 milligram per deciliter
Interval -20.26 to -11.06
|
-19.8 milligram per deciliter
Interval -24.32 to -15.26
|
-2.5 milligram per deciliter
Interval -7.68 to 2.66
|
-22.2 milligram per deciliter
Interval -27.46 to -16.89
|
-30.7 milligram per deciliter
Interval -35.92 to -25.44
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Percent Change at Week 12
|
-37.9 percent change
Interval -43.29 to -32.47
|
3.7 percent change
Interval -2.55 to 9.86
|
-13.5 percent change
Interval -19.6 to -7.37
|
-27.1 percent change
Interval -33.09 to -21.04
|
-1.9 percent change
Interval -7.31 to 3.45
|
-23.5 percent change
Interval -28.94 to -18.07
|
-32.5 percent change
Interval -37.93 to -27.01
|
|
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Percent Change at Week 24
|
-28.7 percent change
Interval -34.5 to -22.99
|
-1.4 percent change
Interval -6.88 to 3.98
|
-16.8 percent change
Interval -22.04 to -11.54
|
-20.6 percent change
Interval -25.76 to -15.42
|
-1.5 percent change
Interval -7.27 to 4.25
|
-23.6 percent change
Interval -29.48 to -17.72
|
-32.5 percent change
Interval -38.29 to -26.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Change at Week 12
|
6.0 milligram per deciliter
Interval 0.25 to 11.68
|
2.2 milligram per deciliter
Interval -2.37 to 6.84
|
7.8 milligram per deciliter
Interval 3.24 to 12.43
|
6.6 milligram per deciliter
Interval 2.09 to 11.11
|
2.1 milligram per deciliter
Interval -3.56 to 7.85
|
3.9 milligram per deciliter
Interval -1.83 to 9.67
|
7.6 milligram per deciliter
Interval 1.84 to 13.33
|
|
Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Change at Week 24
|
4.9 milligram per deciliter
Interval -0.45 to 10.23
|
2.0 milligram per deciliter
Interval -3.76 to 7.72
|
0.6 milligram per deciliter
Interval -5.01 to 6.15
|
-0.2 milligram per deciliter
Interval -5.68 to 5.26
|
0.8 milligram per deciliter
Interval -4.59 to 6.12
|
1.4 milligram per deciliter
Interval -4.14 to 6.86
|
1.2 milligram per deciliter
Interval -4.19 to 6.58
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Percent Change at Week 12
|
9.1 percent change
Interval 2.52 to 15.77
|
2.2 percent change
Interval -0.84 to 5.24
|
5.7 percent change
Interval 2.67 to 8.74
|
4.9 percent change
Interval 1.9 to 7.85
|
2.6 percent change
Interval -4.06 to 9.28
|
2.0 percent change
Interval -4.65 to 8.55
|
4.9 percent change
Interval -1.63 to 11.48
|
|
Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Percent Change at Week 24
|
7.2 percent change
Interval 2.2 to 12.22
|
1.9 percent change
Interval -1.86 to 5.56
|
1.0 percent change
Interval -2.58 to 4.62
|
0.3 percent change
Interval -3.23 to 3.83
|
1.4 percent change
Interval -3.65 to 6.44
|
0.5 percent change
Interval -4.53 to 5.59
|
0.2 percent change
Interval -4.73 to 5.22
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Change at Week 12
|
0.3 milligram per deciliter
Interval -1.65 to 2.33
|
1.7 milligram per deciliter
Interval -0.2 to 3.65
|
1.2 milligram per deciliter
Interval -0.67 to 3.13
|
2.1 milligram per deciliter
Interval 0.25 to 4.01
|
1.0 milligram per deciliter
Interval -0.99 to 2.95
|
1.2 milligram per deciliter
Interval -0.84 to 3.18
|
2.3 milligram per deciliter
Interval 0.29 to 4.32
|
|
Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Change at Week 24
|
0.3 milligram per deciliter
Interval -1.53 to 2.05
|
-0.1 milligram per deciliter
Interval -1.5 to 1.35
|
-0.8 milligram per deciliter
Interval -2.14 to 0.6
|
-0.5 milligram per deciliter
Interval -1.82 to 0.88
|
-0.8 milligram per deciliter
Interval -2.54 to 1.0
|
0.9 milligram per deciliter
Interval -0.94 to 2.72
|
0.1 milligram per deciliter
Interval -1.66 to 1.91
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Percent Change at Week 12
|
8.7 percent change
Interval -14.06 to 31.38
|
5.4 percent change
Interval 0.61 to 10.12
|
3.8 percent change
Interval -0.91 to 8.48
|
6.4 percent change
Interval 1.82 to 11.08
|
8.1 percent change
Interval -14.72 to 30.96
|
18.4 percent change
Interval -4.09 to 40.9
|
8.5 percent change
Interval -13.7 to 30.72
|
|
Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Percent Change at Week 24
|
8.5 percent change
Interval -12.22 to 29.23
|
0.6 percent change
Interval -2.72 to 3.89
|
-1.4 percent change
Interval -4.59 to 1.78
|
-0.7 percent change
Interval -3.89 to 2.39
|
5.5 percent change
Interval -15.36 to 26.3
|
15.3 percent change
Interval -5.26 to 35.81
|
2.8 percent change
Interval -17.47 to 23.03
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol at Week 12 and 24
Change at Week 12
|
-58.6 milligram per deciliter
Standard Deviation 32.90
|
-0.4 milligram per deciliter
Standard Deviation 40.00
|
-19.5 milligram per deciliter
Standard Deviation 27.39
|
-37.6 milligram per deciliter
Standard Deviation 43.58
|
-5.6 milligram per deciliter
Standard Deviation 29.58
|
-35.8 milligram per deciliter
Standard Deviation 24.73
|
-52.7 milligram per deciliter
Standard Deviation 32.67
|
|
Change From Baseline in Total Cholesterol at Week 12 and 24
Change at Week 24
|
-46.9 milligram per deciliter
Standard Deviation 33.83
|
-6.4 milligram per deciliter
Standard Deviation 33.98
|
-24.5 milligram per deciliter
Standard Deviation 25.86
|
-28.6 milligram per deciliter
Standard Deviation 33.61
|
-5.5 milligram per deciliter
Standard Deviation 28.04
|
-31.7 milligram per deciliter
Standard Deviation 32.53
|
-55.0 milligram per deciliter
Standard Deviation 38.67
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 12 and 24
Percent Change at Week 12
|
-31.64 percent change
Standard Deviation 18.012
|
1.24 percent change
Standard Deviation 16.624
|
-10.51 percent change
Standard Deviation 15.318
|
-19.44 percent change
Standard Deviation 22.054
|
-2.35 percent change
Standard Deviation 14.406
|
-18.96 percent change
Standard Deviation 12.299
|
-26.45 percent change
Standard Deviation 14.943
|
|
Percent Change From Baseline in Total Cholesterol at Week 12 and 24
Percent Change at Week 24
|
-24.31 percent change
Standard Deviation 16.491
|
-1.35 percent change
Standard Deviation 14.426
|
-12.38 percent change
Standard Deviation 13.365
|
-14.61 percent change
Standard Deviation 17.302
|
-2.31 percent change
Standard Deviation 13.481
|
-16.70 percent change
Standard Deviation 15.860
|
-27.77 percent change
Standard Deviation 16.993
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Change at Week 12
|
-4.334 milligram per deciliter
Standard Deviation 14.3377
|
1.547 milligram per deciliter
Standard Deviation 12.0489
|
0.502 milligram per deciliter
Standard Deviation 15.1527
|
-5.195 milligram per deciliter
Standard Deviation 12.9577
|
1.654 milligram per deciliter
Standard Deviation 9.8020
|
-0.515 milligram per deciliter
Standard Deviation 17.6889
|
-2.956 milligram per deciliter
Standard Deviation 9.9368
|
|
Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Change at Week 24
|
-3.205 milligram per deciliter
Standard Deviation 11.6380
|
2.718 milligram per deciliter
Standard Deviation 12.9153
|
2.191 milligram per deciliter
Standard Deviation 26.1574
|
-3.281 milligram per deciliter
Standard Deviation 16.9586
|
1.065 milligram per deciliter
Standard Deviation 13.2025
|
-1.893 milligram per deciliter
Standard Deviation 18.8951
|
-3.945 milligram per deciliter
Standard Deviation 16.2841
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Percent Change at Week 12
|
-9.01 percent change
Standard Deviation 35.644
|
9.28 percent change
Standard Deviation 33.809
|
-0.91 percent change
Standard Deviation 26.271
|
-11.93 percent change
Standard Deviation 23.893
|
6.11 percent change
Standard Deviation 30.573
|
40.43 percent change
Standard Deviation 333.949
|
-11.89 percent change
Standard Deviation 22.517
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Percent Change at Week 24
|
0.03 percent change
Standard Deviation 50.256
|
10.18 percent change
Standard Deviation 32.604
|
-0.79 percent change
Standard Deviation 25.066
|
-5.42 percent change
Standard Deviation 22.451
|
8.78 percent change
Standard Deviation 43.596
|
43.97 percent change
Standard Deviation 330.964
|
-10.18 percent change
Standard Deviation 26.612
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Change at Week 12
|
-20.3 milligram per deciliter
Standard Deviation 43.27
|
2.5 milligram per deciliter
Standard Deviation 39.66
|
-5.8 milligram per deciliter
Standard Deviation 38.21
|
-12.1 milligram per deciliter
Standard Deviation 51.36
|
-12.3 milligram per deciliter
Standard Deviation 50.98
|
-11.8 milligram per deciliter
Standard Deviation 35.82
|
-6.0 milligram per deciliter
Standard Deviation 46.43
|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Change at Week 24
|
-24.3 milligram per deciliter
Standard Deviation 57.43
|
-12.1 milligram per deciliter
Standard Deviation 40.35
|
-15.3 milligram per deciliter
Standard Deviation 47.53
|
2.8 milligram per deciliter
Standard Deviation 41.81
|
-4.8 milligram per deciliter
Standard Deviation 46.55
|
-11.5 milligram per deciliter
Standard Deviation 49.20
|
-12.4 milligram per deciliter
Standard Deviation 38.58
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Percent Change at Week 12
|
-15.61 percent change
Standard Deviation 36.099
|
17.58 percent change
Standard Deviation 54.707
|
17.32 percent change
Standard Deviation 94.238
|
2.16 percent change
Standard Deviation 80.149
|
9.62 percent change
Standard Deviation 71.415
|
2.81 percent change
Standard Deviation 54.888
|
-3.77 percent change
Standard Deviation 54.845
|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Percent Change at Week 24
|
-13.28 percent change
Standard Deviation 44.197
|
-3.60 percent change
Standard Deviation 40.646
|
15.72 percent change
Standard Deviation 142.996
|
33.89 percent change
Standard Deviation 131.723
|
20.26 percent change
Standard Deviation 101.188
|
5.34 percent change
Standard Deviation 59.092
|
-9.78 percent change
Standard Deviation 39.626
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides at Week 12 and 24
Change at Week 12
|
-17.6 milligram per deciliter
Standard Deviation 74.45
|
9.0 milligram per deciliter
Standard Deviation 66.03
|
-9.1 milligram per deciliter
Standard Deviation 46.91
|
-15.7 milligram per deciliter
Standard Deviation 58.22
|
-14.1 milligram per deciliter
Standard Deviation 54.92
|
-28.7 milligram per deciliter
Standard Deviation 76.49
|
-17.5 milligram per deciliter
Standard Deviation 87.65
|
|
Change From Baseline in Triglycerides at Week 12 and 24
Change at Week 24
|
-25.5 milligram per deciliter
Standard Deviation 66.92
|
-12.0 milligram per deciliter
Standard Deviation 45.73
|
-20.7 milligram per deciliter
Standard Deviation 54.93
|
6.0 milligram per deciliter
Standard Deviation 50.52
|
-5.0 milligram per deciliter
Standard Deviation 51.01
|
-13.0 milligram per deciliter
Standard Deviation 100.36
|
-25.2 milligram per deciliter
Standard Deviation 83.78
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12 and 24
Percent Change at Week 12
|
-8.93 percent change
Standard Deviation 50.315
|
13.92 percent change
Standard Deviation 49.563
|
-1.88 percent change
Standard Deviation 28.283
|
-5.91 percent change
Standard Deviation 39.286
|
-1.17 percent change
Standard Deviation 42.789
|
-5.01 percent change
Standard Deviation 40.253
|
-7.13 percent change
Standard Deviation 35.229
|
|
Percent Change From Baseline in Triglycerides at Week 12 and 24
Percent Change at Week 24
|
-10.34 percent change
Standard Deviation 32.992
|
-2.01 percent change
Standard Deviation 29.868
|
-7.29 percent change
Standard Deviation 35.954
|
13.90 percent change
Standard Deviation 45.386
|
5.11 percent change
Standard Deviation 52.717
|
6.49 percent change
Standard Deviation 51.960
|
-10.29 percent change
Standard Deviation 32.708
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Change at Week 12
|
-59.6 milligram per deciliter
Standard Deviation 33.23
|
0.6 milligram per deciliter
Standard Deviation 38.04
|
-22.9 milligram per deciliter
Standard Deviation 29.05
|
-40.7 milligram per deciliter
Standard Deviation 44.91
|
-5.7 milligram per deciliter
Standard Deviation 26.92
|
-37.5 milligram per deciliter
Standard Deviation 22.40
|
-55.0 milligram per deciliter
Standard Deviation 32.75
|
|
Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Change at Week 24
|
-47.3 milligram per deciliter
Standard Deviation 33.71
|
-6.8 milligram per deciliter
Standard Deviation 31.49
|
-26.3 milligram per deciliter
Standard Deviation 22.98
|
-28.9 milligram per deciliter
Standard Deviation 34.50
|
-5.4 milligram per deciliter
Standard Deviation 26.84
|
-33.2 milligram per deciliter
Standard Deviation 29.21
|
-55.9 milligram per deciliter
Standard Deviation 38.79
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Full analysis set included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Percent Change at Week 12
|
-44.86 percent change
Standard Deviation 24.258
|
2.76 percent change
Standard Deviation 20.337
|
-17.30 percent change
Standard Deviation 22.324
|
-28.68 percent change
Standard Deviation 30.857
|
-2.28 percent change
Standard Deviation 20.234
|
-28.34 percent change
Standard Deviation 15.836
|
-38.52 percent change
Standard Deviation 21.362
|
|
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Percent Change at Week 24
|
-34.02 percent change
Standard Deviation 22.788
|
-1.78 percent change
Standard Deviation 17.145
|
-19.39 percent change
Standard Deviation 17.304
|
-19.99 percent change
Standard Deviation 24.887
|
-2.02 percent change
Standard Deviation 18.694
|
-24.89 percent change
Standard Deviation 18.938
|
-38.02 percent change
Standard Deviation 23.039
|
SECONDARY outcome
Timeframe: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groupsPopulation: Analysis set included all participants who received at least 1 dose of PF-04950615.
Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=49 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)
|
6.0 percentage of participants
|
9.8 percentage of participants
|
—
|
—
|
6.0 percentage of participants
|
3.9 percentage of participants
|
10.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groupsPopulation: Safety analysis set included all participants who received at least 1 dose of study treatment.
Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=49 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=49 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Injection Site Adverse Events
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
4.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12, 24Population: Analysis set included all participants who received at least 1 dose of PF-04950615. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=49 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentration of PF-04950615 at Week 12 and 24
Week 24
|
0.3752 Microgram per milliliter
Standard Deviation 0.41778
|
1.6459 Microgram per milliliter
Standard Deviation 4.20348
|
—
|
—
|
0.7951 Microgram per milliliter
Standard Deviation 0.78411
|
1.1605 Microgram per milliliter
Standard Deviation 0.72802
|
1.6500 Microgram per milliliter
Standard Deviation 2.77210
|
|
Plasma Concentration of PF-04950615 at Week 12 and 24
Week 12
|
0.5035 Microgram per milliliter
Standard Deviation 0.53400
|
2.2010 Microgram per milliliter
Standard Deviation 3.91444
|
—
|
—
|
1.0157 Microgram per milliliter
Standard Deviation 2.09363
|
1.4737 Microgram per milliliter
Standard Deviation 1.35406
|
2.0516 Microgram per milliliter
Standard Deviation 2.25916
|
SECONDARY outcome
Timeframe: Week 12, 24Population: FAS included all participants who were randomized. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
PF-04950615 150 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 Participants
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
Placebo: Every 14 Days
n=50 Participants
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 Participants
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=52 Participants
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 12: <25 mg/dL
|
10.9 percentage of participants
|
0.0 percentage of participants
|
2.1 percentage of participants
|
6.0 percentage of participants
|
0.0 percentage of participants
|
4.5 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 24: <25 mg/dL
|
2.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 12: <100 mg/dL
|
91.3 percentage of participants
|
34.8 percentage of participants
|
64.6 percentage of participants
|
78.0 percentage of participants
|
48.9 percentage of participants
|
90.9 percentage of participants
|
95.2 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 24: <100 mg/dL
|
91.5 percentage of participants
|
44.2 percentage of participants
|
78.7 percentage of participants
|
79.2 percentage of participants
|
42.6 percentage of participants
|
86.0 percentage of participants
|
91.1 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 12: <70 mg/dL
|
78.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
58.0 percentage of participants
|
4.3 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 24: <70 mg/dL
|
68.1 percentage of participants
|
2.3 percentage of participants
|
21.3 percentage of participants
|
43.8 percentage of participants
|
6.4 percentage of participants
|
55.8 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 12: <40 mg/dL
|
47.8 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
32.0 percentage of participants
|
0.0 percentage of participants
|
6.8 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Week 24: <40 mg/dL
|
17.0 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
4.7 percentage of participants
|
22.2 percentage of participants
|
Adverse Events
Placebo: Every 14 Days
Serious events: 7 serious events
Other events: 35 other events
Deaths: 0 deaths
PF-04950615 50 mg: Every 14 Days
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
PF-04950615 100 mg: Every 14 Days
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
PF-04950615 150 mg: Every 14 Days
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo: Every 28 Days
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
PF-04950615 200 mg: Every 28 Days
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
PF-04950615 300 mg: Every 28 Days
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Every 14 Days
n=49 participants at risk
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 participants at risk
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=51 participants at risk
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
PF-04950615 150 mg: Every 14 Days
n=49 participants at risk
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 participants at risk
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 participants at risk
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 participants at risk
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Exposure via father
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage II
|
4.0%
1/25
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/26
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/26
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/29
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/22
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/31
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/26
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatic dysplasia
|
4.0%
1/25
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/24
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/26
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/29
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/19
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/25
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Aortic aneurysm
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Placebo: Every 14 Days
n=49 participants at risk
Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
|
PF-04950615 50 mg: Every 14 Days
n=50 participants at risk
Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
|
PF-04950615 100 mg: Every 14 Days
n=51 participants at risk
Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
|
PF-04950615 150 mg: Every 14 Days
n=49 participants at risk
Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
|
Placebo: Every 28 Days
n=51 participants at risk
Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
|
PF-04950615 200 mg: Every 28 Days
n=50 participants at risk
Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
|
PF-04950615 300 mg: Every 28 Days
n=51 participants at risk
Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.2%
5/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site erythema
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.2%
5/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.0%
4/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site pain
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.0%
4/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site reaction
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.2%
6/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.2%
5/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Localised infection
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
6/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
16.0%
8/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.7%
7/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.2%
5/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
13.7%
7/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
12.0%
6/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.8%
6/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
7/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.0%
4/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
17.6%
9/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
10.0%
5/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
9.8%
5/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
11.8%
6/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.0%
4/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
5.9%
3/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.0%
3/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
8.0%
4/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
7.8%
4/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
5/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.0%
2/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
4.1%
2/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
8.2%
4/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
3.9%
2/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
6.1%
3/49
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
2.0%
1/50
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
0.00%
0/51
The same event may appear as both an adverse event (AE) and a serious AE. However, what are presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Safety analysis set included all participants who received at least 1 dose of study treatment.
|
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