Trial Outcomes & Findings for A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins (NCT NCT01342211)
NCT ID: NCT01342211
Last Updated: 2017-10-11
Results Overview
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Baseline, Day 85
Results posted on
2017-10-11
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
18
|
19
|
18
|
|
Overall Study
Treated
|
19
|
17
|
18
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
17
|
18
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized, but not Treated
|
0
|
2
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
58.4 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 85Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=16 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
|
-8.91 percent change
Standard Deviation 20.075
|
-13.11 percent change
Standard Deviation 20.786
|
-8.63 percent change
Standard Deviation 30.394
|
-47.20 percent change
Standard Deviation 31.021
|
-56.48 percent change
Standard Deviation 35.289
|
SECONDARY outcome
Timeframe: Day 29, 57, 85Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=16 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 29 <70 mg/dL
|
5.3 percentage of participants
|
6.3 percentage of participants
|
11.8 percentage of participants
|
77.8 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 29 <100 mg/dL
|
47.4 percentage of participants
|
18.8 percentage of participants
|
35.3 percentage of participants
|
94.4 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 57 <70 mg/dL
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
44.4 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 57 <100 mg/dL
|
47.1 percentage of participants
|
13.3 percentage of participants
|
53.3 percentage of participants
|
66.7 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 85 <70 mg/dL
|
5.6 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
66.7 percentage of participants
|
64.7 percentage of participants
|
|
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Day 85 <100 mg/dL
|
33.3 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
88.9 percentage of participants
|
76.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 29, 57, 85Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=16 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Day 29
|
15.8 percentage of participants
|
25.0 percentage of participants
|
11.8 percentage of participants
|
88.9 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Day 57
|
11.8 percentage of participants
|
0 percentage of participants
|
26.7 percentage of participants
|
55.6 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Day 85
|
16.7 percentage of participants
|
18.8 percentage of participants
|
22.2 percentage of participants
|
66.7 percentage of participants
|
82.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29, 57, 85Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 85: TC
|
-10.97 milligram per deciliter (mg/dL)
Standard Deviation 24.41
|
-20.56 milligram per deciliter (mg/dL)
Standard Deviation 31.99
|
-11.56 milligram per deciliter (mg/dL)
Standard Deviation 43.45
|
-62.89 milligram per deciliter (mg/dL)
Standard Deviation 52.73
|
-79.97 milligram per deciliter (mg/dL)
Standard Deviation 55.39
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 85: Non-HDL-C
|
-11.06 milligram per deciliter (mg/dL)
Standard Deviation 26.14
|
-22.38 milligram per deciliter (mg/dL)
Standard Deviation 34.45
|
-13.00 milligram per deciliter (mg/dL)
Standard Deviation 40.28
|
-68.39 milligram per deciliter (mg/dL)
Standard Deviation 54.01
|
-84.79 milligram per deciliter (mg/dL)
Standard Deviation 52.95
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 85: TG
|
2.97 milligram per deciliter (mg/dL)
Standard Deviation 59.087
|
-25.97 milligram per deciliter (mg/dL)
Standard Deviation 49.96
|
-9.39 milligram per deciliter (mg/dL)
Standard Deviation 63.159
|
-6.58 milligram per deciliter (mg/dL)
Standard Deviation 58.104
|
-40.12 milligram per deciliter (mg/dL)
Standard Deviation 73.83
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29: HDL-C
|
0.87 milligram per deciliter (mg/dL)
Standard Deviation 5.627
|
3.59 milligram per deciliter (mg/dL)
Standard Deviation 7.265
|
0.79 milligram per deciliter (mg/dL)
Standard Deviation 5.041
|
4.50 milligram per deciliter (mg/dL)
Standard Deviation 4.624
|
6.00 milligram per deciliter (mg/dL)
Standard Deviation 6.072
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29:TC
|
-10.66 milligram per deciliter (mg/dL)
Standard Deviation 31.13
|
-9.97 milligram per deciliter (mg/dL)
Standard Deviation 29.104
|
-21.94 milligram per deciliter (mg/dL)
Standard Deviation 15.93
|
-81.00 milligram per deciliter (mg/dL)
Standard Deviation 49.61
|
-111.68 milligram per deciliter (mg/dL)
Standard Deviation 28.7
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: HDL-C
|
46.18 milligram per deciliter (mg/dL)
Standard Deviation 10.235
|
51.53 milligram per deciliter (mg/dL)
Standard Deviation 14.084
|
49.11 milligram per deciliter (mg/dL)
Standard Deviation 13.291
|
50.24 milligram per deciliter (mg/dL)
Standard Deviation 11.724
|
44.76 milligram per deciliter (mg/dL)
Standard Deviation 8.189
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: TC
|
202.82 milligram per deciliter (mg/dL)
Standard Deviation 27.96
|
202.03 milligram per deciliter (mg/dL)
Standard Deviation 27.10
|
205.11 milligram per deciliter (mg/dL)
Standard Deviation 22.64
|
202.66 milligram per deciliter (mg/dL)
Standard Deviation 37.98
|
206.91 milligram per deciliter (mg/dL)
Standard Deviation 35.96
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: Non-HDL-C
|
156.63 milligram per deciliter (mg/dL)
Standard Deviation 30.61
|
150.50 milligram per deciliter (mg/dL)
Standard Deviation 29.03
|
156.00 milligram per deciliter (mg/dL)
Standard Deviation 24.08
|
152.42 milligram per deciliter (mg/dL)
Standard Deviation 38.89
|
162.15 milligram per deciliter (mg/dL)
Standard Deviation 37.82
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: TG
|
136.18 milligram per deciliter (mg/dL)
Standard Deviation 58.82
|
137.62 milligram per deciliter (mg/dL)
Standard Deviation 87.56
|
162.83 milligram per deciliter (mg/dL)
Standard Deviation 85.68
|
118.05 milligram per deciliter (mg/dL)
Standard Deviation 47.08
|
172.47 milligram per deciliter (mg/dL)
Standard Deviation 86.49
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: ApoB
|
106.74 milligram per deciliter (mg/dL)
Standard Deviation 19.86
|
105.76 milligram per deciliter (mg/dL)
Standard Deviation 18.21
|
109.83 milligram per deciliter (mg/dL)
Standard Deviation 23.61
|
102.84 milligram per deciliter (mg/dL)
Standard Deviation 22.06
|
109.06 milligram per deciliter (mg/dL)
Standard Deviation 29.49
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline: ApoA1
|
140.32 milligram per deciliter (mg/dL)
Standard Deviation 21.71
|
153.76 milligram per deciliter (mg/dL)
Standard Deviation 22.73
|
146.44 milligram per deciliter (mg/dL)
Standard Deviation 20.35
|
143.11 milligram per deciliter (mg/dL)
Standard Deviation 20.31
|
141.29 milligram per deciliter (mg/dL)
Standard Deviation 16.25
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29: Non-HDL-C
|
-11.53 milligram per deciliter (mg/dL)
Standard Deviation 33.16
|
-13.56 milligram per deciliter (mg/dL)
Standard Deviation 28.17
|
-22.74 milligram per deciliter (mg/dL)
Standard Deviation 14.91
|
-85.50 milligram per deciliter (mg/dL)
Standard Deviation 48.59
|
-117.68 milligram per deciliter (mg/dL)
Standard Deviation 25.9
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29: TG
|
8.66 milligram per deciliter (mg/dL)
Standard Deviation 46.865
|
-3.72 milligram per deciliter (mg/dL)
Standard Deviation 31.384
|
-37.03 milligram per deciliter (mg/dL)
Standard Deviation 66.12
|
-18.97 milligram per deciliter (mg/dL)
Standard Deviation 48.88
|
-46.94 milligram per deciliter (mg/dL)
Standard Deviation 65.20
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29: ApoB
|
-5.05 milligram per deciliter (mg/dL)
Standard Deviation 16.119
|
-9.56 milligram per deciliter (mg/dL)
Standard Deviation 18.155
|
-13.24 milligram per deciliter (mg/dL)
Standard Deviation 15.63
|
-47.13 milligram per deciliter (mg/dL)
Standard Deviation 23.85
|
-67.40 milligram per deciliter (mg/dL)
Standard Deviation 22.03
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 29: ApoA1
|
1.68 milligram per deciliter (mg/dL)
Standard Deviation 10.546
|
2.06 milligram per deciliter (mg/dL)
Standard Deviation 17.117
|
4.29 milligram per deciliter (mg/dL)
Standard Deviation 11.751
|
11.67 milligram per deciliter (mg/dL)
Standard Deviation 14.892
|
7.29 milligram per deciliter (mg/dL)
Standard Deviation 12.875
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: HDL-C
|
-0.74 milligram per deciliter (mg/dL)
Standard Deviation 5.310
|
2.23 milligram per deciliter (mg/dL)
Standard Deviation 8.113
|
2.83 milligram per deciliter (mg/dL)
Standard Deviation 8.004
|
3.17 milligram per deciliter (mg/dL)
Standard Deviation 7.462
|
4.88 milligram per deciliter (mg/dL)
Standard Deviation 7.167
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: TC
|
-13.97 milligram per deciliter (mg/dL)
Standard Deviation 28.37
|
-5.67 milligram per deciliter (mg/dL)
Standard Deviation 18.777
|
-8.20 milligram per deciliter (mg/dL)
Standard Deviation 39.052
|
-51.33 milligram per deciliter (mg/dL)
Standard Deviation 52.08
|
-79.21 milligram per deciliter (mg/dL)
Standard Deviation 52.81
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: Non-HDL-C
|
-13.24 milligram per deciliter (mg/dL)
Standard Deviation 29.52
|
-7.90 milligram per deciliter (mg/dL)
Standard Deviation 21.123
|
-11.03 milligram per deciliter (mg/dL)
Standard Deviation 39.49
|
-54.50 milligram per deciliter (mg/dL)
Standard Deviation 55.71
|
-84.09 milligram per deciliter (mg/dL)
Standard Deviation 54.92
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: TG
|
-1.24 milligram per deciliter (mg/dL)
Standard Deviation 61.405
|
-11.37 milligram per deciliter (mg/dL)
Standard Deviation 36.99
|
-15.73 milligram per deciliter (mg/dL)
Standard Deviation 95.34
|
-4.47 milligram per deciliter (mg/dL)
Standard Deviation 74.402
|
-26.71 milligram per deciliter (mg/dL)
Standard Deviation 49.54
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: ApoB
|
-8.94 milligram per deciliter (mg/dL)
Standard Deviation 14.355
|
-1.07 milligram per deciliter (mg/dL)
Standard Deviation 12.384
|
-3.87 milligram per deciliter (mg/dL)
Standard Deviation 27.302
|
-29.07 milligram per deciliter (mg/dL)
Standard Deviation 31.83
|
-45.90 milligram per deciliter (mg/dL)
Standard Deviation 36.60
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 57: ApoA1
|
-2.59 milligram per deciliter (mg/dL)
Standard Deviation 15.500
|
-0.13 milligram per deciliter (mg/dL)
Standard Deviation 14.020
|
8.47 milligram per deciliter (mg/dL)
Standard Deviation 18.917
|
8.39 milligram per deciliter (mg/dL)
Standard Deviation 20.448
|
10.12 milligram per deciliter (mg/dL)
Standard Deviation 14.168
|
|
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Change at Day 85: HDL-C
|
0.08 milligram per deciliter (mg/dL)
Standard Deviation 5.219
|
1.81 milligram per deciliter (mg/dL)
Standard Deviation 9.377
|
1.44 milligram per deciliter (mg/dL)
Standard Deviation 5.739
|
5.50 milligram per deciliter (mg/dL)
Standard Deviation 7.310
|
4.82 milligram per deciliter (mg/dL)
Standard Deviation 7.671
|
SECONDARY outcome
Timeframe: Baseline, Day 29, 57, 85Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29: HDL-C
|
1.98 percent change
Standard Deviation 11.164
|
5.88 percent change
Standard Deviation 12.764
|
0.27 percent change
Standard Deviation 9.020
|
9.34 percent change
Standard Deviation 10.291
|
12.96 percent change
Standard Deviation 12.116
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29:Non-HDL-C
|
-7.14 percent change
Standard Deviation 20.758
|
-7.57 percent change
Standard Deviation 17.933
|
-14.75 percent change
Standard Deviation 10.320
|
-54.06 percent change
Standard Deviation 23.588
|
-73.23 percent change
Standard Deviation 9.029
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29: TG
|
9.83 percent change
Standard Deviation 35.146
|
-0.50 percent change
Standard Deviation 26.358
|
-15.79 percent change
Standard Deviation 27.131
|
-15.94 percent change
Standard Deviation 34.219
|
-22.55 percent change
Standard Deviation 31.973
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29: ApoA1
|
1.24 percent change
Standard Deviation 7.493
|
1.50 percent change
Standard Deviation 10.896
|
2.88 percent change
Standard Deviation 7.949
|
8.75 percent change
Standard Deviation 11.114
|
5.55 percent change
Standard Deviation 9.613
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: TC
|
-6.91 percent change
Standard Deviation 13.742
|
-2.27 percent change
Standard Deviation 8.829
|
-3.85 percent change
Standard Deviation 18.857
|
-24.17 percent change
Standard Deviation 22.496
|
-37.36 percent change
Standard Deviation 21.167
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: ApoB
|
-8.32 percent change
Standard Deviation 13.214
|
-0.61 percent change
Standard Deviation 12.068
|
-1.51 percent change
Standard Deviation 23.582
|
-27.25 percent change
Standard Deviation 28.265
|
-40.06 percent change
Standard Deviation 29.448
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 85: HDL-C
|
0.87 percent change
Standard Deviation 10.121
|
3.58 percent change
Standard Deviation 19.489
|
3.00 percent change
Standard Deviation 12.481
|
10.67 percent change
Standard Deviation 13.967
|
10.70 percent change
Standard Deviation 17.738
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 85: TG
|
6.16 percent change
Standard Deviation 42.923
|
-8.14 percent change
Standard Deviation 37.105
|
-1.90 percent change
Standard Deviation 37.939
|
-4.22 percent change
Standard Deviation 42.180
|
-14.11 percent change
Standard Deviation 40.324
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: TG
|
5.90 percent change
Standard Deviation 42.384
|
-2.62 percent change
Standard Deviation 21.430
|
1.66 percent change
Standard Deviation 53.893
|
-5.70 percent change
Standard Deviation 53.271
|
-10.76 percent change
Standard Deviation 32.710
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: ApoA1
|
-1.70 percent change
Standard Deviation 11.575
|
0.57 percent change
Standard Deviation 9.918
|
5.31 percent change
Standard Deviation 11.150
|
6.81 percent change
Standard Deviation 15.094
|
7.81 percent change
Standard Deviation 12.152
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29: TC
|
-5.03 percent change
Standard Deviation 15.148
|
-3.88 percent change
Standard Deviation 14.148
|
-10.62 percent change
Standard Deviation 7.813
|
-38.54 percent change
Standard Deviation 19.844
|
-53.52 percent change
Standard Deviation 7.450
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 29: ApoB
|
-4.09 percent change
Standard Deviation 14.429
|
-7.67 percent change
Standard Deviation 15.315
|
-11.27 percent change
Standard Deviation 14.177
|
-44.93 percent change
Standard Deviation 18.320
|
-61.17 percent change
Standard Deviation 9.142
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: HDL-C
|
-1.09 percent change
Standard Deviation 10.708
|
4.96 percent change
Standard Deviation 17.618
|
6.01 percent change
Standard Deviation 15.077
|
6.78 percent change
Standard Deviation 15.755
|
11.06 percent change
Standard Deviation 15.390
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 57: Non-HDL-C
|
-8.34 percent change
Standard Deviation 18.789
|
-4.26 percent change
Standard Deviation 12.999
|
-6.97 percent change
Standard Deviation 23.977
|
-34.84 percent change
Standard Deviation 31.588
|
-50.78 percent change
Standard Deviation 26.254
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 85: TC
|
-5.44 percent change
Standard Deviation 12.468
|
-9.45 percent change
Standard Deviation 14.947
|
-5.52 percent change
Standard Deviation 20.658
|
-28.78 percent change
Standard Deviation 22.023
|
-36.55 percent change
Standard Deviation 26.150
|
|
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Percent change at Day 85: Non-HDL-C
|
-6.78 percent change
Standard Deviation 17.417
|
-13.11 percent change
Standard Deviation 20.428
|
-8.48 percent change
Standard Deviation 24.291
|
-41.28 percent change
Standard Deviation 27.815
|
-50.16 percent change
Standard Deviation 32.255
|
SECONDARY outcome
Timeframe: Day 1 up to Day 141Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
14 participants
|
13 participants
|
13 participants
|
11 participants
|
11 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TESAEs
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment related TEAEs
|
3 participants
|
4 participants
|
2 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 141Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Mild
|
24 adverse events
|
18 adverse events
|
30 adverse events
|
18 adverse events
|
17 adverse events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Moderate
|
2 adverse events
|
16 adverse events
|
13 adverse events
|
12 adverse events
|
10 adverse events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Severe
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: Day 1 up to Day 141Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.
Hematology (hemoglobin\[hgb\],hematocrit,red blood cell\[RBC\]\<0.8\*lower limit of normal\[LLN\],mean cell\[MC\] volume,MC hgb,MC hg concentration \<0.9\*LLN, greater than\[\>\] 1.1\*upper limit of normal\[ULN\], platelet \<0.5\*LLN,\>1.75\*ULN, white blood cell\[WBC\]\<0.6\*LLN,\>1.5\*ULN,neutrophil,lymphocyte \<0.8\*LLN,\>1.2\*ULN,eosinophil,basophil,monocyte \>1.2\*ULN);chemistry(total, direct, indirect bilirubin\[BR\]\>1.5\*ULN,aspartate aminotransferase\[AT\],alanine AT,alkaline phosphatase,gamma-glutyl transferase\>3.0\*ULN,protein,lactate dehydrogenase \<0.8\*LLN,\>1.2\*ULN,creatinine,blood urea nitrogen\>1.3\*ULN,uric acid \>1.2\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN, sodium\<0.95\*LLN,\>1.05\*ULN,glucose\[GL\]\<0.6\*LLN,\>1.5\*ULN,amylase,lipase \>1.5\*ULN,creatinine kinase\>2.0\*ULN);urinalysis(pH \<4.5,\>8,specific gravity\<1.003 , \>1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to \[\>=\]1, RBC, WBC \>=20);coagulation(prothrombin\[PT\],PT international ratio,partial thromboplastin time\>1.1\*ULN).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Laboratory Abnormalities
|
18 participants
|
15 participants
|
17 participants
|
18 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 141Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (\>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of \>=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of \>=25 percent (%) for baseline value of \>200 millisecond (msec) and maximum increase of \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR and QRS interval; maximum increase from baseline of \>30 to \<=60 msec and maximum increase from baseline of \>60 msec for QT interval corrected using the Fridericia's formula (QTCF).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Supine systolic BP: Maximum decrease >=30mmHg
|
1 participants
|
3 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Supine diastolic BP: Maximum decrease >=20mmHg
|
1 participants
|
4 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
PR interval: >=25/50% increase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
QRS interval: >=25/50% increase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
QTCF: Maximum increase >30 to <=60 msec
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Supine systolic BP: Maximum increase >=30mmHg
|
2 participants
|
4 participants
|
3 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
QTCF: Maximum increase >60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Supine diastolic BP: Maximum increase >=20mmHg
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 141Population: Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibody (ADA)
|
0 participants
|
3 participants
|
1 participants
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 29, 57, 71, 85, 99, 127, 141Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 99
|
2.22 mg/dL
Standard Deviation 14.847
|
4.71 mg/dL
Standard Deviation 15.625
|
-1.70 mg/dL
Standard Deviation 10.730
|
4.89 mg/dL
Standard Deviation 24.930
|
-17.52 mg/dL
Standard Deviation 37.185
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 141
|
2.48 mg/dL
Standard Deviation 13.753
|
-0.72 mg/dL
Standard Deviation 15.353
|
0.84 mg/dL
Standard Deviation 12.110
|
3.93 mg/dL
Standard Deviation 14.947
|
-5.52 mg/dL
Standard Deviation 36.935
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Baseline
|
37.46 mg/dL
Standard Deviation 34.809
|
61.05 mg/dL
Standard Deviation 50.109
|
63.66 mg/dL
Standard Deviation 50.594
|
66.29 mg/dL
Standard Deviation 79.992
|
59.73 mg/dL
Standard Deviation 72.611
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 29
|
3.30 mg/dL
Standard Deviation 9.837
|
2.49 mg/dL
Standard Deviation 17.630
|
2.79 mg/dL
Standard Deviation 21.729
|
-5.42 mg/dL
Standard Deviation 17.801
|
-14.08 mg/dL
Standard Deviation 15.693
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 57
|
1.50 mg/dL
Standard Deviation 11.677
|
-2.11 mg/dL
Standard Deviation 7.274
|
0.86 mg/dL
Standard Deviation 22.192
|
-3.44 mg/dL
Standard Deviation 19.032
|
-11.70 mg/dL
Standard Deviation 23.474
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 71
|
1.27 mg/dL
Standard Deviation 13.458
|
-0.84 mg/dL
Standard Deviation 10.351
|
-9.26 mg/dL
Standard Deviation 24.021
|
-4.57 mg/dL
Standard Deviation 16.857
|
-15.45 mg/dL
Standard Deviation 34.324
|
|
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Change at Day 127
|
-3.25 mg/dL
Standard Deviation 28.197
|
2.11 mg/dL
Standard Deviation 11.218
|
-0.59 mg/dL
Standard Deviation 19.654
|
-6.45 mg/dL
Standard Deviation 37.106
|
-8.11 mg/dL
Standard Deviation 31.751
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 29, 57, 71, 85, 99, 127, 141Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 Participants
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 29
|
11.56 percent change
Standard Deviation 25.846
|
14.10 percent change
Standard Deviation 42.815
|
4.23 percent change
Standard Deviation 22.161
|
-21.34 percent change
Standard Deviation 25.694
|
-29.90 percent change
Standard Deviation 22.427
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 57
|
5.13 percent change
Standard Deviation 20.258
|
-0.02 percent change
Standard Deviation 14.398
|
1.38 percent change
Standard Deviation 21.771
|
-10.60 percent change
Standard Deviation 22.427
|
-23.43 percent change
Standard Deviation 27.739
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 71
|
-3.14 percent change
Standard Deviation 27.897
|
-3.43 percent change
Standard Deviation 14.579
|
-21.42 percent change
Standard Deviation 26.676
|
-18.77 percent change
Standard Deviation 23.309
|
-25.95 percent change
Standard Deviation 29.676
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 99
|
0.20 percent change
Standard Deviation 23.623
|
2.66 percent change
Standard Deviation 19.043
|
-3.46 percent change
Standard Deviation 19.600
|
-6.58 percent change
Standard Deviation 5.693
|
-25.39 percent change
Standard Deviation 22.064
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 127
|
-0.08 percent change
Standard Deviation 42.026
|
1.84 percent change
Standard Deviation 15.518
|
-0.14 percent change
Standard Deviation 28.160
|
-11.44 percent change
Standard Deviation 31.828
|
-12.93 percent change
Standard Deviation 27.915
|
|
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Percent change at Day 141
|
7.37 percent change
Standard Deviation 28.842
|
-2.41 percent change
Standard Deviation 20.150
|
-1.27 percent change
Standard Deviation 19.554
|
0.50 percent change
Standard Deviation 22.445
|
-2.41 percent change
Standard Deviation 31.080
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-04950615 0.25 mg/kg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-04950615 1.0 mg/kg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-04950615 3.0 mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-04950615 6.0 mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=19 participants at risk
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 0.25 mg/kg
n=17 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 1.0 mg/kg
n=18 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 3.0 mg/kg
n=19 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
PF-04950615 6.0 mg/kg
n=17 participants at risk
Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Sinus arrest
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Lip dry
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Polyp colorectal
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Axillary pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Fatigue
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Influenza like illness
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
22.2%
4/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
15.8%
3/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
10.5%
2/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Amylase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood glucose increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood pressure increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Lipase increased
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Occult blood positive
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
10.5%
2/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Headache
|
26.3%
5/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
3/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
15.8%
3/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Hyporeflexia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Migraine
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Paraesthesia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Sinus headache
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Syncope
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Renal and urinary disorders
Hypertonic bladder
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Haematoma
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
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