Trial Outcomes & Findings for MK3207 for Treatment of Acute Migraines (3207-005) (NCT NCT00712725)
NCT ID: NCT00712725
Last Updated: 2015-02-02
Results Overview
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
676 participants
Primary outcome timeframe
2 hours postdose
Results posted on
2015-02-02
Participant Flow
Participants were recruited from 47 neurological and general research centers worldwide (19 in the United States and 28 internationally). The primary therapy period was between 2-Jul-08 to 16-Jan-09.
Participants were assessed using the protocol inclusion and exclusion criteria at Visit 1 and, if eligible, were randomized at the same visit.
Participant milestones
| Measure |
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
169
|
39
|
57
|
84
|
86
|
84
|
83
|
74
|
|
Overall Study
COMPLETED
|
140
|
33
|
47
|
67
|
67
|
68
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
29
|
6
|
10
|
17
|
19
|
16
|
22
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
1
|
2
|
2
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
3
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
2
|
|
Overall Study
Lack of Qualifying Event
|
16
|
2
|
6
|
8
|
11
|
13
|
11
|
6
|
|
Overall Study
Protocol Specified Criteria
|
3
|
0
|
1
|
2
|
1
|
0
|
2
|
1
|
Baseline Characteristics
MK3207 for Treatment of Acute Migraines (3207-005)
Baseline characteristics by cohort
| Measure |
Placebo
n=140 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 2.5 mg
n=33 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 5 mg
n=47 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 10 mg
n=67 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 20 mg
n=67 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 50 mg
n=68 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 100 mg
n=62 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
MK3207 200 mg
n=63 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
43.3 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
43.4 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
44.1 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 11.3 • n=31 Participants
|
42.2 years
STANDARD_DEVIATION 10.8 • n=30 Participants
|
42.2 years
STANDARD_DEVIATION 10.9 • n=3 Participants
|
40.5 years
STANDARD_DEVIATION 10.7 • n=6 Participants
|
42.7 years
STANDARD_DEVIATION 10.9 • n=114 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
62 Participants
n=30 Participants
|
52 Participants
n=3 Participants
|
54 Participants
n=6 Participants
|
476 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
71 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
69 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
55 Participants
n=30 Participants
|
53 Participants
n=3 Participants
|
53 Participants
n=6 Participants
|
478 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
132 participants
n=99 Participants
|
32 participants
n=107 Participants
|
46 participants
n=206 Participants
|
62 participants
n=7 Participants
|
63 participants
n=31 Participants
|
64 participants
n=30 Participants
|
59 participants
n=3 Participants
|
59 participants
n=6 Participants
|
517 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
1 participants
n=31 Participants
|
2 participants
n=30 Participants
|
2 participants
n=3 Participants
|
3 participants
n=6 Participants
|
17 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
1 participants
n=3 Participants
|
1 participants
n=6 Participants
|
6 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
3 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
2 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
2 participants
n=114 Participants
|
|
Study Region
United States
|
66 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
45 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
270 Participants
n=114 Participants
|
|
Study Region
Ex-United States
|
74 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
23 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
43 Participants
n=6 Participants
|
277 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=44 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Freedom (PF)
|
13 Participants
|
4 Participants
|
5 Participants
|
16 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=44 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Relief (PR)
|
48 Participants
|
15 Participants
|
19 Participants
|
36 Participants
|
36 Participants
|
41 Participants
|
31 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=44 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Absence of Photophobia
|
51 Participants
|
10 Participants
|
15 Participants
|
32 Participants
|
27 Participants
|
32 Participants
|
26 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=44 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Absence of Phonophobia
|
57 Participants
|
12 Participants
|
18 Participants
|
35 Participants
|
35 Participants
|
38 Participants
|
31 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=43 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Absence of Nausea
|
79 Participants
|
19 Participants
|
25 Participants
|
44 Participants
|
42 Participants
|
44 Participants
|
41 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 2-24 hours postdosePopulation: Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.
Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 Participants
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=44 Participants
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=63 Participants
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=63 Participants
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=65 Participants
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=59 Participants
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=58 Participants
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Sustained Pain Freedom (SPF)
|
10 Participants
|
4 Participants
|
2 Participants
|
13 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
17 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
MK3207 2.5 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
MK3207 5 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
MK3207 10 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MK3207 20 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
MK3207 50 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MK3207 100 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
MK3207 200 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=142 participants at risk
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 participants at risk
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=47 participants at risk
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=66 participants at risk
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=67 participants at risk
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=68 participants at risk
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=62 participants at risk
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=63 participants at risk
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
—
0/0 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Immune system disorders
Hypersensitivity
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
Other adverse events
| Measure |
Placebo
n=142 participants at risk
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 2.5 mg
n=32 participants at risk
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 5 mg
n=47 participants at risk
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 10 mg
n=66 participants at risk
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 20 mg
n=67 participants at risk
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 50 mg
n=68 participants at risk
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 100 mg
n=62 participants at risk
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
MK3207 200 mg
n=63 participants at risk
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Eye disorders
Vision blurred
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
3/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
6.4%
3/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
5.9%
4/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
5/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.3%
2/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.5%
3/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
7.5%
5/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.4%
3/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
8.1%
5/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
6.4%
3/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Chest discomfort
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Chills
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Fatigue
|
2.8%
4/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.3%
2/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
5.9%
4/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Feeling hot
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Irritability
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
General disorders
Malaise
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Investigations
Blood glucose increased
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.8%
3/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Dizziness
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
9.4%
3/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
8.5%
4/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.9%
2/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Dysgeusia
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Headache
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
6.2%
2/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.8%
3/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.9%
2/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Paraesthesia
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Somnolence
|
1.4%
2/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.3%
2/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.0%
2/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.4%
3/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Nervous system disorders
Tremor
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Psychiatric disorders
Insomnia
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
4.3%
2/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.1%
1/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Vascular disorders
Flushing
|
0.70%
1/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
2.1%
1/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.6%
1/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
|
Vascular disorders
Hot flush
|
0.00%
0/142 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/32 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/47 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
1.5%
1/66 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/67 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/68 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
0.00%
0/62 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
3.2%
2/63 • Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Every patient is counted a single time for each applicable specific adverse event. Patients in population are patients who took at least one tablet of the study medication. Placebo is the pooled arm of all matching placebo doses.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER