Trial Outcomes & Findings for Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR) (NCT NCT01190514)
NCT ID: NCT01190514
Last Updated: 2012-01-27
Results Overview
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Results posted on
2012-01-27
Participant Flow
Participants randomized to an open-label treatment sequence beginning in Period 1 with 25 milligrams as 2 tablets (25 mg\*2) in fed state=A; or a 50 mg tablet in fed state=B; or 25 mg\*2 tablets in fasted state=C; or a 50 mg tablet in fasted state=D in a cross-over, 4-period design. Treatment groups sequenced as: ABCD, BADC, CDAB, and DCBA.
Participant milestones
| Measure |
DVS SR 25 mg*2 Fed (A) First
Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg\*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
|
DVS SR 50 mg Fed (B) First
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted (C) First
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
|
DVS SR 50 mg Fasted (D) First
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
First Intervention (Period 1)
STARTED
|
11
|
10
|
10
|
10
|
|
First Intervention (Period 1)
COMPLETED
|
10
|
10
|
10
|
10
|
|
First Intervention (Period 1)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Second Intervention (Period 2)
STARTED
|
10
|
10
|
10
|
10
|
|
Second Intervention (Period 2)
COMPLETED
|
10
|
10
|
10
|
10
|
|
Second Intervention (Period 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention (Period 3)
STARTED
|
10
|
10
|
10
|
10
|
|
Third Intervention (Period 3)
COMPLETED
|
9
|
10
|
10
|
10
|
|
Third Intervention (Period 3)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Fourth Intervention (Period 4)
STARTED
|
9
|
10
|
10
|
10
|
|
Fourth Intervention (Period 4)
COMPLETED
|
9
|
10
|
10
|
10
|
|
Fourth Intervention (Period 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DVS SR 25 mg*2 Fed (A) First
Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg\*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
|
DVS SR 50 mg Fed (B) First
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted (C) First
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
|
DVS SR 50 mg Fasted (D) First
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
First Intervention (Period 1)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Third Intervention (Period 3)
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=41 Participants
Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg\*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg\*2 Fasted (C); or DVS SR 50 mg Fasted (D).
|
|---|---|
|
Age Continuous
|
37.6 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
|
2948 ng*hr/mL
Standard Deviation 726.28
|
2966 ng*hr/mL
Standard Deviation 836.52
|
2632 ng*hr/mL
Standard Deviation 764.41
|
2777 ng*hr/mL
Standard Deviation 893.35
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: PK population; N=number of participants contributing to the mean.
Cmax measured as nanograms divided by milliliters (ng/mL).
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
130.6 ng/mL
Standard Deviation 29.711
|
131.0 ng/mL
Standard Deviation 36.308
|
107.3 ng/mL
Standard Deviation 26.773
|
112.1 ng/mL
Standard Deviation 28.510
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: PK population; N=number of participants contributing to the median.
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
6.00 hours
Interval 4.0 to 12.0
|
8.00 hours
Interval 2.0 to 12.0
|
6.00 hours
Interval 4.0 to 16.0
|
6.00 hours
Interval 4.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: PK population; N=number of participants contributing to the median.
Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t 1/2)
|
10.50 hours
Standard Deviation 2.2478
|
10.72 hours
Standard Deviation 2.8931
|
12.71 hours
Standard Deviation 6.0106
|
11.13 hours
Standard Deviation 2.9444
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: PK population; N=number of participants contributing to the mean.
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
|
3171 ng*hr/mL
Standard Deviation 820.37
|
3216 ng*hr/mL
Standard Deviation 973.36
|
3008 ng*hr/mL
Standard Deviation 1147.6
|
3052 ng*hr/mL
Standard Deviation 1059.9
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dosePopulation: PK population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
DVS SR 25 mg*2 Fed
n=41 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state.
|
DVS SR 50 mg Fed
n=40 Participants
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 Participants
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state.
|
DVS SR 50 mg Fasted
n=39 Participants
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
|
2948 ng*hr/mL
Standard Deviation 726.28
|
2966 ng*hr/mL
Standard Deviation 836.47
|
2631 ng*hr/mL
Standard Deviation 767.89
|
2778 ng*hr/mL
Standard Deviation 894.03
|
Adverse Events
DVS SR 25 mg*2 Fed
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
DVS SR 50 mg Fed
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
DVS SR 25 mg*2 Fasted
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
DVS SR 50 mg Fasted
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DVS SR 25 mg*2 Fed
n=41 participants at risk
DVS SR 25 mg\*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
|
DVS SR 50 mg Fed
n=40 participants at risk
DVS SR 50 mg tablet on Day 1 of study period in fed state.
|
DVS SR 25 mg*2 Fasted
n=40 participants at risk
DVS SR 25 mg\*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
|
DVS SR 50 mg Fasted
n=39 participants at risk
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Eye disorders
Eyelid irritation
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
2/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
10.0%
4/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
General disorders
Asthenia
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
General disorders
Fatigue
|
4.9%
2/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
10.0%
4/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
7.5%
3/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
7.7%
3/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
General disorders
Hunger
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
5.1%
2/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
General disorders
Vessel puncture site haematoma
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
5.1%
2/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.9%
2/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
5.0%
2/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Nervous system disorders
Head discomfort
|
4.9%
2/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
10.0%
4/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
12.5%
5/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
10.3%
4/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Nervous system disorders
Somnolence
|
12.2%
5/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
10.0%
4/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
5.1%
2/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Vascular disorders
Haematoma
|
2.4%
1/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.6%
1/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
|
Vascular disorders
Hot flush
|
0.00%
0/41 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
2.5%
1/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
5.0%
2/40 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
0.00%
0/39 • Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER