Trial Outcomes & Findings for A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period (NCT NCT00792636)
NCT ID: NCT00792636
Last Updated: 2016-11-23
Results Overview
The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
407 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2016-11-23
Participant Flow
The number of participants defined as starting the study in the Participant Flow module includes only those participants randomized to treatment.
Participant milestones
| Measure |
Sumatriptan/Naproxen
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
|
Sumatriptan
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Overall Study
STARTED
|
135
|
136
|
136
|
|
Overall Study
COMPLETED
|
67
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
68
|
81
|
81
|
Reasons for withdrawal
| Measure |
Sumatriptan/Naproxen
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
|
Sumatriptan
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
17
|
23
|
20
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
19
|
20
|
20
|
|
Overall Study
Lost to Follow-up
|
13
|
19
|
14
|
|
Overall Study
Withdrew Consent
|
10
|
13
|
9
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
13
|
|
Overall Study
Adverse Event
|
4
|
2
|
3
|
|
Overall Study
Investigator Discretion
|
2
|
0
|
2
|
Baseline Characteristics
A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
Baseline characteristics by cohort
| Measure |
Sumatriptan/Naproxen
n=122 Participants
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
|
Sumatriptan
n=112 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=118 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
39.1 Years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 11.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
108 participants
n=5 Participants
|
96 participants
n=7 Participants
|
105 participants
n=5 Participants
|
309 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian and White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Average Number of Migraine Attacks per Month
|
4.5 migraines
STANDARD_DEVIATION 1.76 • n=5 Participants
|
4.2 migraines
STANDARD_DEVIATION 1.67 • n=7 Participants
|
4.6 migraines
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.4 migraines
STANDARD_DEVIATION 1.75 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.
The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Systolic, Baseline, n=120
|
111.7 millimeters of mercury (mmHg)
Standard Deviation 9.00
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Systolic, Month 6, n=48
|
107.1 millimeters of mercury (mmHg)
Standard Deviation 9.59
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Systolic, Change from Baseline, n=47
|
-2.9 millimeters of mercury (mmHg)
Standard Deviation 5.24
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Diastolic, Baseline, n=120
|
76.0 millimeters of mercury (mmHg)
Standard Deviation 6.83
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Diastolic, Month 6, n=48
|
73.0 millimeters of mercury (mmHg)
Standard Deviation 6.84
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Diastolic, Change from Baseline, n=47
|
-2.1 millimeters of mercury (mmHg)
Standard Deviation 4.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Outcome measures
| Measure |
Sumatriptan
n=109 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Systolic, Baseline, n=109, 115
|
110.8 mmHg
Standard Deviation 9.15
|
110.1 mmHg
Standard Deviation 9.19
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Systolic, Month 6, n=42, 37
|
109.4 mmHg
Standard Deviation 7.70
|
108.2 mmHg
Standard Deviation 9.16
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Systolic, Change from Baseline, n=41, 36
|
-2.8 mmHg
Standard Deviation 5.69
|
-1.8 mmHg
Standard Deviation 6.53
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Diastolic, Baseline, n=109, 115
|
75.7 mmHg
Standard Deviation 7.38
|
74.7 mmHg
Standard Deviation 7.00
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Diastolic, Month 6, n=42, 37
|
73.9 mmHg
Standard Deviation 7.03
|
74.3 mmHg
Standard Deviation 8.47
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Diastolic, Change from Baseline, n=41, 36
|
-1.6 mmHg
Standard Deviation 4.21
|
-0.6 mmHg
Standard Deviation 5.50
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=109 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Systolic, Baseline, n=120, 109
|
111.7 mmHg
Standard Error 9.00
|
110.8 mmHg
Standard Error 9.15
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Systolic, Month 6, n=48, 42
|
107.1 mmHg
Standard Error 9.59
|
109.4 mmHg
Standard Error 7.70
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Systolic, Change from Baseline, n=47, 41
|
-2.9 mmHg
Standard Error 5.24
|
-2.8 mmHg
Standard Error 5.69
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Diastolic, Baseline, n=120, 109
|
76.0 mmHg
Standard Error 6.83
|
75.7 mmHg
Standard Error 7.38
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Diastolic, Month 6, n=48, 42
|
73.0 mmHg
Standard Error 6.84
|
73.9 mmHg
Standard Error 7.03
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Diastolic, Change from Baseline, n=47, 41
|
-2.1 mmHg
Standard Error 4.44
|
-1.6 mmHg
Standard Error 4.21
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Diastolic, Baseline, n=120, 115
|
76.0 mmHg
Standard Deviation 6.83
|
74.7 mmHg
Standard Deviation 7.00
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Systolic, Baseline, n=120, 115
|
111.7 mmHg
Standard Deviation 9.00
|
110.1 mmHg
Standard Deviation 9.19
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Systolic, Month 6, n=48, 37
|
107.1 mmHg
Standard Deviation 9.59
|
108.2 mmHg
Standard Deviation 9.16
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Systolic, Change from Baseline, n=47, 36
|
-2.9 mmHg
Standard Deviation 5.24
|
-1.8 mmHg
Standard Deviation 6.53
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Diastolic, Month 6, n=48, 37
|
73.0 mmHg
Standard Deviation 6.84
|
74.3 mmHg
Standard Deviation 8.47
|
—
|
|
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Diastolic, Change from Baseline, n=47, 36
|
-2.1 mmHg
Standard Deviation 4.44
|
-0.6 mmHg
Standard Deviation 5.50
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for \> 6 migraines/month group due to lack of convergence.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Systolic, <4 migraines per month
|
-2.0 mmHg
Interval -3.5 to -0.5
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Systolic, 4-6 migraines per month
|
-3.3 mmHg
Interval -7.0 to 0.4
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Systolic, >=4 migraines per month
|
-3.7 mmHg
Interval -6.7 to -0.7
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Diastolic, <4 migraines per month
|
-1.2 mmHg
Interval -2.5 to 0.0
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Diastolic, 4-6 migraines per month
|
-5.3 mmHg
Interval -9.9 to -0.6
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Diastolic, >=4 migraines per month
|
-4.1 mmHg
Interval -7.2 to -1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Systolic, <1.3 doses per migraine
|
-0.3 mmHg
Interval -2.7 to 2.0
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Systolic, 1.3-1.7 doses per migraine
|
-2.7 mmHg
Interval -5.3 to -0.2
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Systolic, >1.7 doses per migraine
|
-3.8 mmHg
Interval -6.2 to -1.5
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Diastolic, <1.3 doses per migraine
|
-0.4 mmHg
Interval -2.2 to 1.5
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Diastolic, 1.3-1.7 doses per migraines
|
-0.9 mmHg
Interval -2.9 to 1.2
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Diastolic, >1.7 doses per migraine
|
-3.2 mmHg
Interval -5.3 to -1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the \>14 doses/month groups due to lack of convergence.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Systolic,<6 doses per month
|
-1.6 mmHg
Interval -3.1 to 0.0
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Systolic, 6-10 doses per month
|
-4.6 mmHg
Interval -7.4 to -1.8
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Systolic, >=6 doses per month
|
-4.3 mmHg
Interval -7.1 to -1.6
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Diastolic,<6 doses per month
|
-1.0 mmHg
Interval -2.2 to 0.3
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Diastolic, 6-10 doses per month
|
-3.7 mmHg
Interval -7.1 to -0.4
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Diastolic, >=6 doses per month
|
-3.5 mmHg
Interval -6.3 to -0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the \>90 total dose groups due to lack of convergence.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Systolic, <30 total doses
|
-1.2 mmHg
Interval -2.9 to 0.4
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Systolic, 30-60 total doses
|
-3.4 mmHg
Interval -6.0 to -0.7
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Systolic, >=30 total doses
|
-3.7 mmHg
Interval -6.0 to -1.4
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Diastolic, <30 total doses
|
-0.6 mmHg
Interval -2.0 to 0.7
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Diastolic, 30-60 total doses
|
-3.3 mmHg
Interval -5.8 to -0.8
|
—
|
—
|
|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Diastolic, >=30 total doses
|
-3.6 mmHg
Interval -5.7 to -1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population. Only participants with valid blood pressure measurements were analyzed.
The number of participants with an increase of \>=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=109 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
|
53 participants
|
57 participants
|
63 participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population. Only participants with valid blood pressure measurements were analyzed.
The number of participants with an increase of \>=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=109 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
|
72 participants
|
65 participants
|
77 participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population
The number of participants with any valid two-day consecutive average systolic blood pressure measurement of \>=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=112 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=118 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study
|
2 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population
The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of \>=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=112 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=118 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg
|
10 participants
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population. Only participants with valid blood pressure measurements were analyzed.
Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of \>=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=109 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure
|
42.5 days
Interval 2.0 to 177.0
|
32.5 days
Interval 3.0 to 118.0
|
18.5 days
Interval 3.0 to 124.0
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population. Only participants with valid blood pressure measurements were analyzed.
Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of \>=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
Outcome measures
| Measure |
Sumatriptan
n=120 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=109 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=115 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure
|
51 days
Interval 2.0 to 140.0
|
50.5 days
Interval 3.0 to 161.0
|
26 days
Interval 3.0 to 124.0
|
SECONDARY outcome
Timeframe: Baseline to End of Study (6-month study duration)Population: ITT Population
The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or \>=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of \>=30 mmHg systolic or \>=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic \>=140 mmHg or diastolic \>=90 mmHg on consecutive clinic visits \>=2 weeks apart.
Outcome measures
| Measure |
Sumatriptan
n=122 Participants
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=112 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
Naproxen
n=118 Participants
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Number of Participants Withdrawn From the Study Due to Blood Pressure Changes
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Sumatriptan/Naproxen
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Sumatriptan
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Naproxen
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sumatriptan/Naproxen
n=127 participants at risk
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
|
Sumatriptan
n=120 participants at risk
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=127 participants at risk
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
General disorders
Chest pain
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Infections and infestations
Cellulitis
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Nervous system disorders
Convulsion
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion induced
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.83%
1/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
Other adverse events
| Measure |
Sumatriptan/Naproxen
n=127 participants at risk
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
|
Sumatriptan
n=120 participants at risk
Sumatriptan 85 mg tablet taken after migraine attack
|
Naproxen
n=127 participants at risk
Naproxen sodium 500 mg tablet taken after migraine attack
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.1%
4/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
5.0%
6/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
3.9%
5/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
5.0%
6/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
2.4%
3/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Infections and infestations
Sinusitis
|
2.4%
3/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
1.7%
2/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
4.2%
5/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Nervous system disorders
Dizziness
|
3.9%
5/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
4.2%
5/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Nervous system disorders
Somnolence
|
1.6%
2/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
2.5%
3/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
1.6%
2/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
2.5%
3/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
1.6%
2/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
2/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
3.3%
4/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
4/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
1.7%
2/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Immune system disorders
Seasonal allergy
|
2.4%
3/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.83%
1/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
2.4%
3/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
2.5%
3/120 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
0.79%
1/127 • Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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