Trial Outcomes & Findings for PF-00489791 For The Treatment Of Raynaud's (NCT NCT01090492)
NCT ID: NCT01090492
Last Updated: 2018-05-16
Results Overview
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2018-05-16
Participant Flow
A total of 243 participants were stratified into 2 cohorts (Primary Raynaud's phenomenon\[PRP\] and secondary RP\[SRP\]), who entered a 2-week placebo run-in period (to establish baseline), followed by a cross-over period (first 4 week treatment period,then a 2 week placebo washout,then 4 week treatment period) and then a 2-week placebo run-out period.
Participant milestones
| Measure |
PRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 4mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 4 mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
First Intervention Period (4 Weeks)
STARTED
|
27
|
29
|
29
|
28
|
33
|
32
|
32
|
33
|
|
First Intervention Period (4 Weeks)
COMPLETED
|
26
|
24
|
26
|
22
|
29
|
30
|
31
|
27
|
|
First Intervention Period (4 Weeks)
NOT COMPLETED
|
1
|
5
|
3
|
6
|
4
|
2
|
1
|
6
|
|
Placebo Washout Period ( 2 Weeks)
STARTED
|
26
|
24
|
26
|
22
|
29
|
30
|
31
|
27
|
|
Placebo Washout Period ( 2 Weeks)
COMPLETED
|
26
|
24
|
26
|
22
|
29
|
30
|
31
|
27
|
|
Placebo Washout Period ( 2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period (4 Weeks)
STARTED
|
26
|
24
|
26
|
22
|
29
|
30
|
31
|
27
|
|
Second Intervention Period (4 Weeks)
COMPLETED
|
25
|
22
|
24
|
22
|
27
|
29
|
22
|
25
|
|
Second Intervention Period (4 Weeks)
NOT COMPLETED
|
1
|
2
|
2
|
0
|
2
|
1
|
9
|
2
|
Reasons for withdrawal
| Measure |
PRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 4mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 4 mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
First Intervention Period (4 Weeks)
Protocol Violation
|
1
|
1
|
1
|
2
|
0
|
0
|
1
|
0
|
|
First Intervention Period (4 Weeks)
Did not meet inclusion criteria
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
|
First Intervention Period (4 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention Period (4 Weeks)
Other
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
|
First Intervention Period (4 Weeks)
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention Period (4 Weeks)
Adverse Event
|
0
|
2
|
0
|
3
|
1
|
2
|
0
|
5
|
|
Second Intervention Period (4 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Second Intervention Period (4 Weeks)
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period (4 Weeks)
Other
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period (4 Weeks)
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
1
|
7
|
1
|
|
Second Intervention Period (4 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
PF-00489791 For The Treatment Of Raynaud's
Baseline characteristics by cohort
| Measure |
PRP Cohort: Placebo First, Then PF-00489791 4 mg
n=27 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 4mg First, Then Placebo
n=29 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: Placebo First, Then PF-00489791 20 mg
n=29 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
PRP Cohort: PF-00489791 20 mg First, Then Placebo
n=28 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 4 mg
n=33 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 4 mg First, Then Placebo
n=32 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: Placebo First, Then PF-00489791 20 mg
n=32 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
SRP Cohort: PF-00489791 20 mg First, Then Placebo
n=33 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Between 18 to 44 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
95 Participants
n=42 Participants
|
|
Age, Customized
Between 45 to 64 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
146 Participants
n=42 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
220 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Per-protocol analysis set (PPAS) included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion.
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=34 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=39 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=73 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=47 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=36 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=83 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
Baseline
|
3.04 units on a scale
Standard Deviation 1.899
|
2.90 units on a scale
Standard Deviation 2.160
|
2.98 units on a scale
Standard Deviation 1.958
|
3.14 units on a scale
Standard Deviation 2.431
|
2.53 units on a scale
Standard Deviation 1.833
|
2.97 units on a scale
Standard Deviation 2.492
|
|
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
Change at Week 4
|
-0.76 units on a scale
Standard Deviation 1.901
|
-1.05 units on a scale
Standard Deviation 1.771
|
-0.61 units on a scale
Standard Deviation 1.404
|
-0.82 units on a scale
Standard Deviation 1.624
|
-0.15 units on a scale
Standard Deviation 1.090
|
-0.24 units on a scale
Standard Deviation 1.437
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=34 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=39 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=73 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=47 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=36 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=83 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Baseline
|
22.06 Raynaud's attacks
Standard Deviation 20.587
|
16.31 Raynaud's attacks
Standard Deviation 10.885
|
20.19 Raynaud's attacks
Standard Deviation 17.802
|
22.80 Raynaud's attacks
Standard Deviation 16.270
|
23.70 Raynaud's attacks
Standard Deviation 20.909
|
23.08 Raynaud's attacks
Standard Deviation 20.698
|
|
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change at Week 1
|
-3.75 Raynaud's attacks
Standard Deviation 7.494
|
-2.47 Raynaud's attacks
Standard Deviation 6.477
|
-1.41 Raynaud's attacks
Standard Deviation 7.934
|
-3.17 Raynaud's attacks
Standard Deviation 7.994
|
-4.49 Raynaud's attacks
Standard Deviation 14.692
|
-2.36 Raynaud's attacks
Standard Deviation 11.850
|
|
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change at Week 2
|
-5.30 Raynaud's attacks
Standard Deviation 9.487
|
-2.36 Raynaud's attacks
Standard Deviation 8.371
|
-2.45 Raynaud's attacks
Standard Deviation 11.107
|
-3.76 Raynaud's attacks
Standard Deviation 9.028
|
-4.43 Raynaud's attacks
Standard Deviation 17.312
|
-1.87 Raynaud's attacks
Standard Deviation 11.051
|
|
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change at Week 3
|
-4.66 Raynaud's attacks
Standard Deviation 10.559
|
-4.86 Raynaud's attacks
Standard Deviation 5.681
|
-4.03 Raynaud's attacks
Standard Deviation 10.396
|
-4.25 Raynaud's attacks
Standard Deviation 11.408
|
-3.75 Raynaud's attacks
Standard Deviation 8.601
|
-1.93 Raynaud's attacks
Standard Deviation 9.487
|
|
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change at Week 4
|
-4.85 Raynaud's attacks
Standard Deviation 13.008
|
-3.07 Raynaud's attacks
Standard Deviation 7.118
|
-3.65 Raynaud's attacks
Standard Deviation 10.460
|
-3.89 Raynaud's attacks
Standard Deviation 8.326
|
-2.68 Raynaud's attacks
Standard Deviation 10.002
|
-2.25 Raynaud's attacks
Standard Deviation 10.624
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=34 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=39 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=73 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=47 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=36 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=83 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Baseline
|
17.69 minutes per attack
Standard Deviation 13.184
|
22.23 minutes per attack
Standard Deviation 36.562
|
19.61 minutes per attack
Standard Deviation 40.603
|
19.37 minutes per attack
Standard Deviation 18.929
|
19.07 minutes per attack
Standard Deviation 18.196
|
19.91 minutes per attack
Standard Deviation 19.886
|
|
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Change at Week 4
|
-2.89 minutes per attack
Standard Deviation 7.480
|
-5.63 minutes per attack
Standard Deviation 43.067
|
-1.41 minutes per attack
Standard Deviation 12.348
|
-3.92 minutes per attack
Standard Deviation 11.336
|
-2.61 minutes per attack
Standard Deviation 9.593
|
-1.65 minutes per attack
Standard Deviation 10.609
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4Population: PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=34 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=39 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=73 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=47 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=36 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=83 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Change at Week 2
|
-0.94 units on a scale
Standard Deviation 1.745
|
-0.61 units on a scale
Standard Deviation 1.524
|
-0.48 units on a scale
Standard Deviation 1.337
|
-0.68 units on a scale
Standard Deviation 1.740
|
-0.33 units on a scale
Standard Deviation 1.321
|
-0.24 units on a scale
Standard Deviation 1.306
|
|
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Change at Week 3
|
-0.82 units on a scale
Standard Deviation 1.720
|
-1.12 units on a scale
Standard Deviation 1.664
|
-0.62 units on a scale
Standard Deviation 1.262
|
-0.80 units on a scale
Standard Deviation 1.836
|
-0.55 units on a scale
Standard Deviation 1.081
|
-0.33 units on a scale
Standard Deviation 1.269
|
|
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Change at Week 4
|
-0.80 units on a scale
Standard Deviation 1.842
|
-1.14 units on a scale
Standard Deviation 1.820
|
-0.63 units on a scale
Standard Deviation 1.423
|
-0.77 units on a scale
Standard Deviation 1.922
|
-0.35 units on a scale
Standard Deviation 1.115
|
-0.27 units on a scale
Standard Deviation 1.466
|
|
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Baseline
|
2.84 units on a scale
Standard Deviation 2.074
|
2.78 units on a scale
Standard Deviation 2.348
|
2.80 units on a scale
Standard Deviation 2.064
|
3.33 units on a scale
Standard Deviation 2.614
|
2.54 units on a scale
Standard Deviation 1.895
|
3.10 units on a scale
Standard Deviation 2.753
|
|
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Change at Week 1
|
-0.72 units on a scale
Standard Deviation 1.525
|
-0.74 units on a scale
Standard Deviation 1.266
|
-0.26 units on a scale
Standard Deviation 1.205
|
-0.53 units on a scale
Standard Deviation 1.440
|
-0.32 units on a scale
Standard Deviation 1.276
|
-0.17 units on a scale
Standard Deviation 1.272
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28Population: PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=47 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=36 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=83 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
Baseline
|
10 participants
|
7 participants
|
16 participants
|
—
|
—
|
—
|
|
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
With Decrease at Day 14
|
7 participants
|
1 participants
|
6 participants
|
—
|
—
|
—
|
|
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
With Decrease at Day 28
|
9 participants
|
5 participants
|
7 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)Population: Analysis population included participants who received 1 dose of study drug and were analyzed for pharmacokinetic parameters. Here, Overall number of participants signifies participants evaluable for either first or second intervention period and number analyzed signifies those participants who were evaluable at specified time points.
Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=55 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=54 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=61 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=64 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 15
|
0.1523 mcg/mL
Standard Deviation 0.0855
|
0.5907 mcg/mL
Standard Deviation 0.3736
|
0.1756 mcg/mL
Standard Deviation 0.09038
|
0.7718 mcg/mL
Standard Deviation 0.4991
|
—
|
—
|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 29
|
0.1489 mcg/mL
Standard Deviation 0.0854
|
0.6525 mcg/mL
Standard Deviation 0.3822
|
0.1776 mcg/mL
Standard Deviation 0.08508
|
0.7577 mcg/mL
Standard Deviation 0.4137
|
—
|
—
|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 43
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
|
—
|
—
|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 57
|
0.1088 mcg/mL
Standard Deviation 0.0629
|
0.6890 mcg/mL
Standard Deviation 0.4318
|
0.1167 mcg/mL
Standard Deviation 0.05644
|
0.7565 mcg/mL
Standard Deviation 0.6224
|
—
|
—
|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 71
|
0.1178 mcg/mL
Standard Deviation 0.0614
|
0.6337 mcg/mL
Standard Deviation 0.3745
|
0.1224 mcg/mL
Standard Deviation 0.0638
|
0.6639 mcg/mL
Standard Deviation 0.5834
|
—
|
—
|
|
Plasma Concentration of PF-00489791 and Its Metabolites
Day 1
|
0.0058 mcg/mL
Standard Deviation 0.0314
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
|
NA mcg/mL
Standard Deviation NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening up to 28 days after last study dose (up to 98 days)Population: Analysis population included all randomized participants who took at least 1 dose of study medication along with at least 1 on-treatment laboratory test result.
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than \[\<\] 0.8\*lower limit of normal\[LLN\]); leukocytes (\<0.6 LLN /greater than \[\>\] 1.5\*upper LN \[ULN\]; platelets (\<0.5\*LLN/\>1.75\*ULN); neutrophils, lymphocytes (\<0.8\* LLN/\>1.2\*ULN); eosinophils, basophils, monocytes (\>1.2\*ULN); bilirubin (\>1.5\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (\>3\*ULN); BUN, creatinine (\>1.3\*ULN); glucose (\<0.6 LLN/\>1.5\*ULN); uric acid (\>1.2\*ULN); sodium (\<0.95\*LLN/\>1.05\*ULN); potassium, calcium, chloride, bicarbonate (\<0.9\*LLN/\>1.1\*ULN); albumin, total protein (\<0.8\*LLN/\>1.2\*ULN); creatine kinase (\>2.0\*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (\>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=50 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=48 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=98 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=57 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=60 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=114 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
2 participants
|
4 participants
|
14 participants
|
5 participants
|
13 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Screening up to 28 days after last study dose (up to 98 days)Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication.
Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=55 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=54 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=102 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=61 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=64 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=122 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening up to 28 days after last study dose (up to 98 days)Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication.
ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.
Outcome measures
| Measure |
PF-00489791 4 mg (PRP)
n=55 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=54 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=102 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=61 Participants
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=64 Participants
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=122 Participants
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Values
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
PF-00489791 4 mg (PRP)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
PF-00489791 20 mg (PRP)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo (PRP)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
PF-00489791 4 mg (SRP)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
PF-00489791 20 mg (SRP)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo (SRP)
Serious events: 1 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PF-00489791 4 mg (PRP)
n=55 participants at risk
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=54 participants at risk
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=102 participants at risk
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=61 participants at risk
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=64 participants at risk
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=122 participants at risk
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
PF-00489791 4 mg (PRP)
n=55 participants at risk
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 20 mg (PRP)
n=54 participants at risk
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
Placebo (PRP)
n=102 participants at risk
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
|
PF-00489791 4 mg (SRP)
n=61 participants at risk
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
PF-00489791 20 mg (SRP)
n=64 participants at risk
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
Placebo (SRP)
n=122 participants at risk
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
6.2%
4/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.5%
3/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Eye discharge
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Eye oedema
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Eyelid oedema
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Periorbital oedema
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Photophobia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.9%
4/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
10.9%
7/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
9.3%
5/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
5/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.7%
3/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.5%
3/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Face oedema
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.9%
3/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Feeling hot
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.9%
3/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Inflammation
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.7%
3/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.9%
3/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.7%
3/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Ulcer
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Furuncle
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
4/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Localised infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
3/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.9%
3/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.7%
3/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
4/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Otitis media
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
9.8%
10/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.1%
5/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood potassium increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Heart rate increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Investigations
Weight increased
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
7.8%
5/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
2/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
5.6%
3/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
6.6%
4/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
10.9%
7/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.5%
3/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
2/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
5.6%
3/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of cornea
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.9%
3/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.7%
3/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.3%
4/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
14.5%
8/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
25.9%
14/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
8.8%
9/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
14.8%
9/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
32.8%
21/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
9.8%
12/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
2.0%
2/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Orgasm abnormal
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.1%
2/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Flushing
|
5.5%
3/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
3.7%
2/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.98%
1/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
4.9%
3/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
6.2%
4/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.82%
1/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
2/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.6%
1/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Phlebitis superficial
|
1.8%
1/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/55
Safety analysis population included all participants who received at least 1 dose of study medication.
|
1.9%
1/54
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/102
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/61
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/64
Safety analysis population included all participants who received at least 1 dose of study medication.
|
0.00%
0/122
Safety analysis population included all participants who received at least 1 dose of study medication.
|
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