Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087) (NCT NCT00894556)
NCT ID: NCT00894556
Last Updated: 2024-05-10
Results Overview
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2024-05-10
Participant Flow
Patients were recruited at 21 study centers in the United States. First Patient In: 10-Jun-2009; First Patient Treated: 26-Jun-2009 Last Patient Last Visit: 12-Jan-2010; Last Patient Treated: 25-Dec-2009
Participants who met entry criteria but had evidence of suicidality or were severely depressed (based on questionnaire scores) were excluded. Within 2 months of entry, participants were to treat a moderate/ severe migraine attack with sumatriptan 100 mg and were randomized if they still had moderate or severe pain at 2 hours post-dose.
Participant milestones
| Measure |
Rizatriptan / Rizatriptan / Placebo
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
|
Rizatriptan / Placebo / Rizatriptan
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
|
Placebo / Rizatriptan / Rizatriptan
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
|
Sumatriptan 100 mg
Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
|
|---|---|---|---|---|
|
Baseline Phase
STARTED
|
0
|
0
|
0
|
194
|
|
Baseline Phase
COMPLETED
|
0
|
0
|
0
|
109
|
|
Baseline Phase
NOT COMPLETED
|
0
|
0
|
0
|
85
|
|
Treatment Phase
STARTED
|
37
|
36
|
36
|
0
|
|
Treatment Phase
COMPLETED
|
33
|
32
|
35
|
0
|
|
Treatment Phase
NOT COMPLETED
|
4
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Rizatriptan / Rizatriptan / Placebo
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
|
Rizatriptan / Placebo / Rizatriptan
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
|
Placebo / Rizatriptan / Rizatriptan
Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
|
Sumatriptan 100 mg
Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
|
|---|---|---|---|---|
|
Baseline Phase
Did not meet Randomization Criteria
|
0
|
0
|
0
|
85
|
|
Treatment Phase
Lost to Follow-up
|
2
|
3
|
1
|
0
|
|
Treatment Phase
Lack of Qualifying Event
|
2
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Baseline characteristics by cohort
| Measure |
Rizatriptan / Rizatriptan / Placebo
n=37 Participants
The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
|
Rizatriptan / Placebo / Rizatriptan
n=36 Participants
The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
|
Placebo / Rizatriptan / Rizatriptan
n=36 Participants
The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
43.6 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
43.5 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
43.1 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
103 Participants
n=7 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (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
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.
Outcome measures
| Measure |
Rizatriptan
n=202 Evaluable Attacks
Migraines were treated with Rizatriptan 10 mg ODT.
Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups.
|
Placebo
n=99 Evaluable Attacks
Migraines were treated with placebo
|
|---|---|---|
|
Pain Relief (PR)
Resulting in PR at 2 hours post dose
|
102 attacks
|
21 attacks
|
|
Pain Relief (PR)
Not resulting in PR at 2 hours post dose
|
100 attacks
|
78 attacks
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.
Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.
Outcome measures
| Measure |
Rizatriptan
n=202 Evaluable Attacks
Migraines were treated with Rizatriptan 10 mg ODT.
Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups.
|
Placebo
n=99 Evaluable Attacks
Migraines were treated with placebo
|
|---|---|---|
|
Pain Freedom (PF)
Resulting in PF at 2 hours post dose
|
46 attacks
|
12 attacks
|
|
Pain Freedom (PF)
Not resulting in PF at 2 hours post dose
|
156 attacks
|
87 attacks
|
Adverse Events
Rizatriptan 10 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sumatriptan 100 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rizatriptan 10 mg
n=102 participants at risk
Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).
Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.
Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently.
|
Placebo
n=100 participants at risk
|
Sumatriptan 100 mg
n=194 participants at risk
Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as "Baseline Phase"
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Ear and labyrinth disorders
Motion Sickness - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Eye disorders
Eyelid Pain - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Abdominal pain - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Abdominal pain upper - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Dry mouth - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Nausea - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
2.1%
4/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Paraesthesia oral - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Asthenia - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Chest discomfort - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.5%
3/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Fatigue - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Oedema peripheral - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Pain - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Infections and infestations
Hordeolum - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Infections and infestations
Nasopharyngitis - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Infections and infestations
Rhinitis - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Injury, poisoning and procedural complications
Foot fracture - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Investigations
Heart rate increased - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Musculoskeletal and connective tissue disorders
Back pain - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Musculoskeletal and connective tissue disorders
Neck pain - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Cognitive disorder - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Dizziness - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
4.6%
9/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Headache - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.5%
3/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Migraine - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Paraesthesia - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.5%
3/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Sinus headache - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Psychiatric disorders
Anxiety - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Psychiatric disorders
Insomnia - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Reproductive system and breast disorders
Metrorrhagia - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
2/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Vascular disorders
Hot flush - Baseline Phase
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.52%
1/194 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Eye disorders
Eyelid ptosis - Treatment Phase
|
0.00%
0/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Eye disorders
Vision blurred - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Abdominal pain upper - Treatment Phase
|
2.0%
2/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Diarrhoea - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Gastrointestinal disorders
Nausea - Treatment Phase
|
3.9%
4/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Fatigue - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Feeling of relaxation - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Gait disturbance - Treatment Phase
|
0.00%
0/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Influenza like illness - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
General disorders
Sensation of pressure - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Injury, poisoning and procedural complications
Facial bones fracture - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Injury, poisoning and procedural complications
Wrist fracture - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Musculoskeletal and connective tissue disorders
Myokymia - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Cognitive disorder - Treatment Phase
|
0.00%
0/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Dizziness - Treatment Phase
|
3.9%
4/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Dysgeusia - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Paraesthesia - Treatment Phase
|
2.0%
2/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
1.0%
1/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Sinus headache - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Somnolence - Treatment Phase
|
2.0%
2/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Syncope - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Nervous system disorders
Insomnia - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
|
Vascular disorders
Hot flush - Treatment Phase
|
0.98%
1/102 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
0.00%
0/100 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
—
0/0 • Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
|
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