Trial Outcomes & Findings for Evaluation of Pazopanib on Bleeding in Subjects With Hereditary Haemorrhagic Telangiectasia (NCT NCT02204371)
NCT ID: NCT02204371
Last Updated: 2017-07-06
Results Overview
The Epistaxis (nose bleeding) severity score (ESS) is a 6-item par-reported outcome measure designed to be a uniform epistaxis severity scoring system to assess the effectiveness of specific treatments on HHT-related epistaxis. Four questions document epistaxis frequency, duration, intensity and need for treatment, whereas two additional questions detail the presence of anemia and if a par has required a blood transfusion as a consequence of their epistaxis. Questions are variably weighted and results are tabulated on a 0-10 scale (0=no disease, 10 = severe disease). The minimum important difference is 0.71. Baseline is the Day1 pre-dose assessment value. Change from Baseline is calculated as the Post dose value at the indicated visit minus the Baseline value. Par were evaluated at Baseline, Treatment period (Weeks 6 and 12) and Follow-up period (Weeks 16, 20, 24 and 28). Only those par available at the indicated timepoints were analysed (specified by n=X in the category titles).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28
Results posted on
2017-07-06
Participant Flow
This study was planned as a two part study (Part A and Part B). As efficacy based dose escalation stopping criteria was met, there was only one dose cohort (50 milligrams \[mg\] once daily cohort) in Part A. The study was stopped prior to Part B being conducted.
Run-in period started at the screening visit or up to 2 weeks after the screening visit. Participants (par.) were stabilized on a anemia management plan for 4-8 weeks prior to the first dose. Unstable par. were allowed to continue in the run-in period for additional 4 weeks. 2 par. did not met the eligibility criteria.
Participant milestones
| Measure |
GW786034 50 mg Once Daily
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
GW786034 50 mg Once Daily
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Evaluation of Pazopanib on Bleeding in Subjects With Hereditary Haemorrhagic Telangiectasia
Baseline characteristics by cohort
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Age, Continuous
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57.3 Years
STANDARD_DEVIATION 9.14 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
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7 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28Population: Pharmacodynamic Population: All par. who received at least one dose of study treatment (Safety Population) and who also provided data from at least one pharmacodynamic assessment (hemoglobin, ferritin, epistaxis daily diary).
The Epistaxis (nose bleeding) severity score (ESS) is a 6-item par-reported outcome measure designed to be a uniform epistaxis severity scoring system to assess the effectiveness of specific treatments on HHT-related epistaxis. Four questions document epistaxis frequency, duration, intensity and need for treatment, whereas two additional questions detail the presence of anemia and if a par has required a blood transfusion as a consequence of their epistaxis. Questions are variably weighted and results are tabulated on a 0-10 scale (0=no disease, 10 = severe disease). The minimum important difference is 0.71. Baseline is the Day1 pre-dose assessment value. Change from Baseline is calculated as the Post dose value at the indicated visit minus the Baseline value. Par were evaluated at Baseline, Treatment period (Weeks 6 and 12) and Follow-up period (Weeks 16, 20, 24 and 28). Only those par available at the indicated timepoints were analysed (specified by n=X in the category titles).
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Week 6, n=7
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-0.59 Scores on a scale
Standard Deviation 0.802
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Week 12, n=6
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-1.16 Scores on a scale
Standard Deviation 1.023
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Follow-up Week 16, n=7
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-0.60 Scores on a scale
Standard Deviation 1.299
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Follow-up Week 20, n=6
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-1.41 Scores on a scale
Standard Deviation 1.674
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Follow-up Week 24, n=5
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-1.27 Scores on a scale
Standard Deviation 1.519
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Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
Follow-up Week 28, n=5
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-0.08 Scores on a scale
Standard Deviation 1.920
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PRIMARY outcome
Timeframe: Baseline, Week 9, Week 10.5 and Week 12Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.
For post-Baseline hemoglobin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-transfusion hemoglobin values have been included in the analyses. Baseline hemoglobin value is the average of the last two measurements during the run-in period. . Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of hemoglobin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of hemoglobin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=6 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)
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7.58 Grams per liter (g/L)
Standard Deviation 17.543
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PRIMARY outcome
Timeframe: Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
Only pre-transfusion hemoglobin values have been included in the analyses. All hemoglobin values that fall within 5 days of packed red blood cells (PRBC) transfusion are considered as post-transfusion values. Baseline hemoglobin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the Post dose value at the indicated visit minus the Baseline value. Par. were evaluated at Treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and Follow-up period (Weeks 16, 20, 24 and 28).
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 1.5, n=7
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7.50 g/L
Standard Deviation 11.113
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 3, n=6
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11.92 g/L
Standard Deviation 13.492
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 4.5, n=7
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7.50 g/L
Standard Deviation 22.042
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 6, n=7
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6.48 g/L
Standard Deviation 19.967
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 7.5, n=6
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8.83 g/L
Standard Deviation 12.770
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 9, n=6
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6.67 g/L
Standard Deviation 14.865
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 10.5, n=6
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7.50 g/L
Standard Deviation 15.485
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Change From Baseline in Hemoglobin at the Indicated Time Points
Week 12, n=6
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8.58 g/L
Standard Deviation 25.150
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Change From Baseline in Hemoglobin at the Indicated Time Points
Follow-Up Week 16, n=7
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7.00 g/L
Standard Deviation 22.739
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Change From Baseline in Hemoglobin at the Indicated Time Points
Follow-Up Week 20, n=6
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7.56 g/L
Standard Deviation 19.212
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Change From Baseline in Hemoglobin at the Indicated Time Points
Follow-Up Week 24, n=5
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4.93 g/L
Standard Deviation 11.086
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Change From Baseline in Hemoglobin at the Indicated Time Points
Follow-Up Week 28, n=5
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-3.80 g/L
Standard Deviation 7.926
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PRIMARY outcome
Timeframe: Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)Population: Pharmacodynamic Population
Duration of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 57 - 70
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140 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 71 - 84
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79 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 85 - 98
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104 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 99 - 112
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165 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 113 - 120
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127 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, Baseline
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361 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 1 - 2
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63 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5 OT Day 3 - 16
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378 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 17 - 30
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404 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, Baseline
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26 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day1-13
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28 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 14-27
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32 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 28-41
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32 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 42-55
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34 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 56-69
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26 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 70 - 83
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30 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 1-14
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22 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 15 - 28
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28 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 29 - 42
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34 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 43 - 56
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43 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 57 - 70
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33 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 71 - 84
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27 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 85 - 98
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46 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 99 - 112
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66 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, Baseline
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846 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day1-5
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301 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 6 - 19
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966 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 20 - 33
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1288 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 34 - 47
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980 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 48 - 61
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589 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 62 - 75
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594 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 76 - 89
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386 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 1 - 14
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240 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 15 - 28
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191 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 29 - 42
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426 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 43 - 56
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261 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 57 - 70
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236 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 71 - 84
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115 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 85 - 98
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467 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 99
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14 Minutes
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, Baseline
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130 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day1 - 14
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210 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 15 - 28
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132 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 29 - 42
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118 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 43 - 56
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84 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day57 - 70
|
65 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day71 - 84
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68 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant , F Day 1 - 14
|
127 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 15 - 28
|
8 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 29 - 42
|
48 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 43 - 56
|
63 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 57 - 70
|
70 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 71 - 84
|
36 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 85 - 98
|
51 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 99 - 112
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46 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 113 - 115
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5 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, Baseline
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269 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day1
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30 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 2 - 15
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312 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 16 - 29
|
125 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 30 - 43
|
122 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 44 - 57
|
93 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 58 - 71
|
40 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 72 - 85
|
40 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 1-14
|
55 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 15 - 28
|
84 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 29 - 42
|
232 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 43 - 56
|
95 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 31 - 44
|
396 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 45 - 58
|
211 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 59 - 72
|
278 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 73 - 86
|
202 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 1-14
|
224 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 15 - 28
|
130 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 29 - 42
|
163 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 43 - 56
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151 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 57 - 70
|
207 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 71 - 84
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170 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 85 - 98
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176 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 99 - 112
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253 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 113 - 118
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94 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, Baseline
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26 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 1
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0 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 2 - 15
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12 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 16 - 29
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28 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 30 - 43
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19 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 1-14
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19 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 15 - 28
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15 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 29 - 42
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8 Minutes
|
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Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 43 - 56
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26 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, Baseline
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213 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 1 - 14
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190 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 15 - 28
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58 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 29 - 42
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110 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 43 - 56
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15 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 57 - 70
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36 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 71 - 84
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53 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 1-14
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40 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 15 - 28
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114 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 29 - 42
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68 Minutes
|
|
Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 43 - 54
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87 Minutes
|
PRIMARY outcome
Timeframe: Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)Population: Pharmacodynamic Population
Frequency of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
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|---|---|
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Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, Baseline
|
21 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day1-13
|
23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 14-27
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23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 28-41
|
22 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 42-55
|
23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 56-69
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20 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 70 - 83
|
25 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 1-14
|
23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 15 - 28
|
24 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 29 - 42
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 43 - 56
|
30 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 57 - 70
|
21 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 71 - 84
|
23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 85 - 98
|
31 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 99 - 112
|
34 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, Baseline
|
42 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day1-5
|
17 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 6 - 19
|
42 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 20 - 33
|
55 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 34 - 47
|
44 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 48 - 61
|
32 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 62 - 75
|
42 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 76 - 89
|
37 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 1 - 14
|
32 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 15 - 28
|
21 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 29 - 42
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 43 - 56
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 57 - 70
|
33 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 71 - 84
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 85 - 98
|
34 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 99
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3 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, Baseline
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day1 - 14
|
17 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 15 - 28
|
16 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 29 - 42
|
13 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 43 - 56
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day57 - 70
|
8 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day71 - 84
|
13 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant , F Day 1 - 14
|
12 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 15 - 28
|
3 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 29 - 42
|
8 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 43 - 56
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 57 - 70
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 71 - 84
|
5 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 85 - 98
|
5 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 99 - 112
|
9 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 113 - 115
|
2 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, Baseline
|
27 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day1
|
1 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 2 - 15
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 16 - 29
|
18 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 30 - 43
|
19 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 44 - 57
|
17 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 58 - 71
|
7 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 72 - 85
|
6 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 1-14
|
6 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 15 - 28
|
9 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 29 - 42
|
18 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 43 - 56
|
12 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 57 - 70
|
19 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 71 - 84
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 85 - 98
|
12 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 99 - 112
|
14 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 113 - 120
|
10 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, Baseline
|
35 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 1 - 2
|
6 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5 OT Day 3 - 16
|
33 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 17 - 30
|
37 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 31 - 44
|
34 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 45 - 58
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 59 - 72
|
34 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 73 - 86
|
30 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 1-14
|
30 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 15 - 28
|
19 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 29 - 42
|
22 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 43 - 56
|
23 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 57 - 70
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 71 - 84
|
25 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 85 - 98
|
27 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 99 - 112
|
31 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 113 - 118
|
9 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, Baseline
|
18 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 1
|
0 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 2 - 15
|
13 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 16 - 29
|
28 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 30 - 43
|
19 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 1-14
|
17 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 15 - 28
|
13 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 29 - 42
|
9 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 43 - 56
|
17 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, Baseline
|
13 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 1 - 14
|
9 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 15 - 28
|
5 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 29 - 42
|
11 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 43 - 56
|
5 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 57 - 70
|
5 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 71 - 84
|
6 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 1-14
|
7 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 15 - 28
|
12 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 29 - 42
|
7 Number of nosebleeds
|
|
Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 43 - 54
|
6 Number of nosebleeds
|
PRIMARY outcome
Timeframe: Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)Population: Pharmacodynamic Population
Intensity of epistaxis based on daily diaries has been reported as total gushing and total non gushing from Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, Baseline, Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, Baseline, Total Non-Gushing
|
19 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day1-13, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day1-13, Total Non-Gushing
|
23 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 14-27, Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 14-27, Total Non-Gushing
|
20 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 28-41, Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 28-41, Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 42-55, Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 42-55, Total Non-Gushing
|
20 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 56-69, Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 56-69, Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 70 - 83, Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, OT Day 70 - 83, Total Non-Gushing
|
23 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 1-14, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 1-14, Total Non-Gushing
|
23 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 15 - 28, Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 15 - 28, Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 29 - 42 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 29 - 42 , Total Non-Gushing
|
28 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 43 - 56, Total Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 43 - 56, Total Non-Gushing
|
25 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 57 - 70 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 57 - 70 , Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 71 - 84 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 71 - 84 , Total Non-Gushing
|
23 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 85 - 98 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 85 - 98 , Total Non-Gushing
|
27 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 99 - 112 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 1, F Day 99 - 112 , Total Non-Gushing
|
28 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, Baseline, Total Gushing
|
25 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, Baseline, Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day1-5, Total Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day1-5, Total Non-Gushing
|
12 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 6 - 19 , Total Gushing
|
24 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 6 - 19 , Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 20 - 33 , Total Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 20 - 33 , Total Non-Gushing
|
38 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 34 - 47, Total Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 34 - 47 , Total Non-Gushing
|
34 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 48 - 61 , Total Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 48 - 61 , Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 62 - 75 , Total Gushing
|
20 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 62 - 75 , Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 76 - 89 , Total Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, OT Day 76 - 89 , Total Non-Gushing
|
20 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 1 - 14 , Total Gushing
|
14 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 1 - 14 , Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 15 - 28 , Total Gushing
|
14 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 15 - 28 , Total Non-Gushing
|
7 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 29 - 42 , Total Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 29 - 42 , Total Non-Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 43 - 56 , Total Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 43 - 56 , Total Non-Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 57 - 70 , Total Gushing
|
14 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 57 - 70 , Total Non-Gushing
|
19 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 71 - 84 , Total Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 71 - 84 , Total Non-Gushing
|
19 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 85 - 98 , Total Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 85 - 98 , Total Non-Gushing
|
21 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 99 , Total Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 2, F Day 99, Total Non-Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, Baseline , Total Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, Baseline, Total Non-Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day1 - 14 , Total Gushing
|
8 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day1 - 14 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 15 - 28 , Total Gushing
|
7 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 15 - 28 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 29 - 42 , Total Gushing
|
12 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 29 - 42 , Total Non-Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 43 - 56 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 43 - 56 , Total Non-Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 57 - 70 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 57 - 70 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 71 - 84 , Total Gushing
|
7 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, OT Day 71 - 84 , Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant , F Day 1 - 14 , Total Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant , F Day 1 - 14 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 15 - 28 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 15 - 28 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 29 - 42, Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 29 - 42 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 43 - 56 , Total Gushing
|
7 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 43 - 56 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 57 - 70 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 57 - 70 , Total Non-Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 71 - 84 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 71 - 84 , Total Non-Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 85 - 98 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 85 - 98 , Total Non-Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 99 - 112 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 99 - 112 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 113 - 115 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 3, F Day 113 - 115 , Total Non-Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, Baseline, Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, Baseline, Total Non-Gushing
|
24 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day1, Total Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day1, Total Non-Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 2 - 15 , Total Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 2 - 15 , Total Non-Gushing
|
19 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 16 - 29 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 16 - 29 , Total Non-Gushing
|
16 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 30 - 43 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 30 - 43 , Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 44 - 57 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 44 - 57 , Total Non-Gushing
|
15 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 58 - 71 , Total Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 58 - 71 , Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 72 - 85 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, OT Day 72 - 85 , Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 1-14, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 1-14, Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 15 - 28 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 15 - 28 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 29 - 42 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 29 - 42 , Total Non-Gushing
|
12 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 43 - 56 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 43 - 56 , Total Non-Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 57 - 70 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 57 - 70 , Total Non-Gushing
|
16 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 71 - 84 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 71 - 84 , Total Non-Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 85 - 98 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 85 - 98 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 99 - 112 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 99 - 112 , Total Non-Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 113 - 120 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 4, F Day 113 - 120 , Total Non-Gushing
|
8 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, Baseline, Total Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, Baseline, Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 1 - 2 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 1 - 2 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5 OT Day 3 - 16 , Total Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5 OT Day 3 - 16 , Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 17 - 30 , Total Gushing
|
15 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 17 - 30 , Total Non-Gushing
|
22 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 31 - 44 , Total Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 31 - 44 , Total Non-Gushing
|
23 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 45 - 58 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 45 - 58 , Total Non-Gushing
|
24 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 59 - 72 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 59 - 72 , Total Non-Gushing
|
28 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 73 - 86, Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, OT Day 73 - 86 , Total Non-Gushing
|
26 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 1-14, Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 1-14, Total Non-Gushing
|
27 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 15 - 28 , Total Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 15 - 28 , Total Non-Gushing
|
15 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 29 - 42, Total Gushing
|
12 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 29 - 42 , Total Non-Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 43 - 56 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 15 - 28 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 43 - 56 , Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 57 - 70 , Total Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 57 - 70 , Total Non-Gushing
|
15 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 99 - 112 , Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 113 - 118 , Total Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 15 - 28 , Total Non-Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 113 - 118 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, Baseline, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, Baseline, Total Non-Gushing
|
18 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 1, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 1 , Total Non-Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 2 - 15 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 2 - 15 , Total Non-Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 16 - 29 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 16 - 29 , Total Non-Gushing
|
28 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 30 - 43 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, OT Day 30 - 43 , Total Non-Gushing
|
19 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 71 - 84 , Total Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 71 - 84 , Total Non-Gushing
|
16 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 85 - 98 , Total Gushing
|
11 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 85 - 98 , Total Non-Gushing
|
16 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 5, F Day 99 - 112 , Total Gushing
|
13 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 29 - 42 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 29 - 42 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 43 - 56 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 43 - 56 , Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, Baseline, Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, Baseline, Total Non-Gushing
|
10 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 1 - 14 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 1-14, Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 1 - 14 , Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 15 - 28 , Total Gushing
|
0 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 15 - 28 , Total Non-Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 29 - 42 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 6, F Day 1-14, Total Non-Gushing
|
17 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 29 - 42 , Total Non-Gushing
|
9 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 43 - 56 , Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 43 - 56 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 57 - 70 , Total Gushing
|
1 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 57 - 70 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 71 - 84 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, OT Day 71 - 84 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 1-14, Total Gushing
|
2 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 1-14, Total Non-Gushing
|
5 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 15 - 28 , Total Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 15 - 28 , Total Non-Gushing
|
6 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 29 - 42 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 29 - 42 , Total Non-Gushing
|
4 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 43 - 54 , Total Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
|
Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)
Participant 7, F Day 43 - 54 , Total Non-Gushing
|
3 Number of gushing/non-gushing nosebleeds
|
PRIMARY outcome
Timeframe: Last 4 weeks of run-in and during last 4 weeks of dosing periodPopulation: Pharmacodynamic Population
Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the last 4 weeks of run-in and during last 4 weeks of dosing period was listed. Individual participant data has been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 1, Baseline
|
300 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 1, Dosing period, Day 1 - 27
|
300 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 1, Dosing period, Day 28 - 55
|
300 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 1, Dosing period, Day 56 - 83
|
600 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 2, Baseline
|
1000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 2, Dosing period, Day 1 - 5
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 2, Dosing period, Day 6 - 33
|
2000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 2, Dosing period, Day 34 - 61
|
1000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 2, Dosing period, Day 62 - 89
|
1000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 3, Baseline
|
3000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 3, Dosing period, Day 1 - 28
|
1000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 3, Dosing period, Day 29 - 56
|
1000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 3, Dosing period, Day 57 - 84
|
2000 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 4, Baseline
|
800 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 4, Dosing period, Day 1
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 4, Dosing period, Day 2 - 29
|
800 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 4, Dosing period, Day 30 - 57
|
400 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 4, Dosing period, Day 58 - 85
|
300 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 5, Baseline
|
750 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 5, Dosing period, Day 1 - 2
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 5, Dosing period, Day 3 - 30
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 5, Dosing period, Day 31 - 58
|
1500 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 5, Dosing period, Day 59 - 86
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 6, Baseline
|
4150 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 6, Dosing period, Day 1 - 15
|
2460 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 6, Dosing period, Day 16 - 43
|
3640 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 7, Baseline
|
510 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 7, Dosing period, Day 1 - 28
|
510 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 7, Dosing period, Day 29 - 56
|
0 Milligram
|
|
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
Participant 7, Dosing period, Day 57 - 84
|
1020 Milligram
|
PRIMARY outcome
Timeframe: Last 4 weeks of run-in and during last 4 weeks of dosing periodPopulation: Pharmacodynamic Population
Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the entire dosing and follow-up period was listed by 4 week interval. Individual participant data has been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Baseline
|
300 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 1 - 27
|
300 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 28 - 55
|
300 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 56 - 83
|
600 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 1 - 28
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 29 - 56
|
300 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 57 - 84
|
600 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 85 - 112
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Baseline
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 1 - 5
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 6 - 33
|
2000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 34 - 61
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 62 - 89
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 1 - 28
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 29 - 56
|
500 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 57 - 84
|
1500 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 85 - 106
|
500 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Baseline
|
3000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Dosing period, Day 1 - 28
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Dosing period, Day 29 - 56
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Dosing period, Day 57 - 84
|
2000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 1 - 28
|
3000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 29 - 56
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 57 - 84
|
2000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 85 - 112
|
2000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 113
|
1000 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Baseline
|
800 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 1
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 2 - 29
|
800 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 30 - 57
|
400 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 58 - 85
|
300 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 1 - 28
|
100 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 29 - 56
|
200 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 57 - 84
|
200 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 85 - 112
|
200 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 113
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Baseline
|
750 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 1 - 2
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 3 - 30
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 31 - 58
|
1500 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 59 - 86
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 1 - 28
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 29 - 56
|
750 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 57 - 84
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 85 - 112
|
750 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 113
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Baseline
|
4150 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Dosing period, Day 1 - 15
|
2460 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Dosing period, Day 16 - 43
|
3640 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Follow up, Day 1 - 28
|
3640 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Follow up, Day 29 - 56
|
4660 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Baseline
|
510 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Dosing period, Day 1 - 28
|
510 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Dosing period, Day 29 - 56
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Dosing period, Day 57 - 84
|
1020 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Follow up, Day 1 - 28
|
0 Milligram
|
|
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Follow up, Day 29 - 55
|
1020 Milligram
|
PRIMARY outcome
Timeframe: Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-upPopulation: Pharmacodynamic Population
Baseline PRBC transfused is defined as the number of units of PRBC transfused during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total units of PRBCs transfused during the entire dosing and follow-up period was listed by 4 week interval. Individual participant data been reported.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 1 - 27
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 28 - 55
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Dosing period, Day 56 - 83
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 1, Follow up, Day 85 - 112
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 1 - 5
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 6 - 33
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 34 - 61
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Dosing period, Day 62 - 89
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 2, Follow up, Day 85 - 106
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Baseline
|
2 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Dosing period, Day 1 - 28
|
2 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Dosing period, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Dosing period, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 85 - 112
|
2 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 3, Follow up, Day 113
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 1
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 2 - 29
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 30 - 57
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Dosing period, Day 58 - 85
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 85 - 112
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 4, Follow up, Day 113
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 1 - 2
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 3 - 30
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 31 - 58
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Dosing period, Day 59 - 86
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 85 - 112
|
2 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 5, Follow up, Day 113
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Baseline
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Dosing period, Day 1 - 15
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Dosing period, Day 16 - 43
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 6, Follow up, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Dosing period, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Dosing period, Day 29 - 56
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Dosing period, Day 57 - 84
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Follow up, Day 1 - 28
|
0 Number of units
|
|
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
Participant 7, Follow up, Day 29 - 55
|
0 Number of units
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 10.5 and Week 12Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.
For post-Baseline ferritin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-infusion ferritin values have been included in the analyses. Baseline ferritin value is the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of ferritin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of ferritin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=6 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)
|
-73.17 micrograms per liter (µg per L)
Standard Deviation 115.016
|
SECONDARY outcome
Timeframe: Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
Only pre-infusion ferritin values have been included in the analyses. All ferritin measurements that fall within 5 days of iron infusion date are considered post-infusion. Baseline ferritin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline is calculated as the difference between the Post dose value at indicated visit minus Baseline value. Par. were evaluated at baseline, treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and follow-up period (16, 20, 24 and 28).
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 1.5, n=4
|
-73.75 µg per L
Standard Deviation 223.827
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 3, n=6
|
-59.33 µg per L
Standard Deviation 182.538
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 4.5, n=5
|
-118.30 µg per L
Standard Deviation 184.946
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 6, n=7
|
7.07 µg per L
Standard Deviation 62.727
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 7.5, n=2
|
-31.75 µg per L
Standard Deviation 67.529
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 9, n=6
|
-48.83 µg per L
Standard Deviation 86.762
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 10.5, n=5
|
-82.90 µg per L
Standard Deviation 127.769
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Week 12, n=3
|
-111.67 µg per L
Standard Deviation 231.107
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Follow-Up Week 16, n=7
|
-85.36 µg per L
Standard Deviation 154.078
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Follow-Up Week 20, n=6
|
-14.56 µg per L
Standard Deviation 119.056
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Follow-Up Week 24, n=4
|
-70.25 µg per L
Standard Deviation 237.869
|
|
Change From Baseline in Ferritin at the Indicated Time Points
Follow-Up Week 28, n=5
|
1.90 µg per L
Standard Deviation 82.750
|
SECONDARY outcome
Timeframe: Day (D) 1, Week (W) 6 and Week 12Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
SF-36v2 is a generic HR QOL instrument with 36 items covering 8 subscales (SS) clustering into 2 global scores, the physical component summary score (PCS: physical functioning (PF), role physical (RP), bodily pain (BP), and general health (GH)) and mental component summary score (MCS: vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH)). All scores are normalized so that mean score for a representative US population = 50, with a standard deviation = 10. Information was used to observe a direction in overall QOL. Ranges are shown below. Higher scores represent better QOL and minimum important differences are PF, 3; RP, 3; BP, 3; GH, 2; VT, 2; SF, 3; RE, 4; and MH, 3 PCS, 2; MCS, 3. Response Consistency Index (RCI) measures the consistency of responses to individual survey responses. Lower the score the more consistent the individual responses. SF-6D Health Utility Index (HUI) Score = 0 (worst measured health state) to 1 (best measured health state).
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP (0-100 score), D1, n=7
|
58.29 Scores on a scale
Standard Deviation 20.966
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP (0-100 score), W6, n=7
|
70.86 Scores on a scale
Standard Deviation 29.396
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP (0-100 score), W12, n=6
|
53.67 Scores on a scale
Standard Deviation 19.232
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH (0-100 score), D1, n=7
|
50.14 Scores on a scale
Standard Deviation 28.510
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH (0-100 score), W6, n=7
|
51.86 Scores on a scale
Standard Deviation 26.448
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH (0-100 score), W12, n=6
|
49.67 Scores on a scale
Standard Deviation 17.351
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH (0-100 score), D1, n=7
|
61.43 Scores on a scale
Standard Deviation 22.678
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH (0-100 score), W6, n=7
|
70.00 Scores on a scale
Standard Deviation 21.602
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH (0-100 score), W12, n=6
|
71.67 Scores on a scale
Standard Deviation 12.111
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF (0-100 score), D1, n=7
|
52.86 Scores on a scale
Standard Deviation 26.590
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF (0-100 score), W6, n=7
|
55.72 Scores on a scale
Standard Deviation 24.397
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF (0-100 score), W12, n=6
|
68.33 Scores on a scale
Standard Deviation 12.906
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE (0-100 score), D1, n=7
|
63.10 Scores on a scale
Standard Deviation 31.861
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE (0-100 score), W6, n=7
|
83.33 Scores on a scale
Standard Deviation 23.570
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE (0-100 score), W12, n=6
|
75.00 Scores on a scale
Standard Deviation 16.667
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP (0-100 score), D1, n=7
|
58.04 Scores on a scale
Standard Deviation 30.129
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP (0-100 score), W6, n=7
|
66.96 Scores on a scale
Standard Deviation 23.583
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP (0-100 score), W12, n=6
|
66.67 Scores on a scale
Standard Deviation 25.820
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF (0-100 score), D1, n=7
|
66.07 Scores on a scale
Standard Deviation 25.733
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF (0-100 score), W6, n=7
|
83.93 Scores on a scale
Standard Deviation 17.252
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF (0-100 score), W12, n=6
|
62.50 Scores on a scale
Standard Deviation 20.917
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT (0-100 score), D1, n=7
|
42.86 Scores on a scale
Standard Deviation 18.196
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT (0-100 score), W6, n=7
|
53.57 Scores on a scale
Standard Deviation 20.684
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT (0-100 score), W12, n=6
|
47.92 Scores on a scale
Standard Deviation 11.637
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP(norm-based score), D1, n=7 (21.68-62.0 score)
|
44.40 Scores on a scale
Standard Deviation 8.278
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP(norm-based score), W6, n=7 (21.68-62.0 score)
|
49.37 Scores on a scale
Standard Deviation 11.605
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
BP(norm-based score), W12, n=6 (21.68-62.0 score)
|
42.58 Scores on a scale
Standard Deviation 7.592
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH(norm-based score), D1, n=7 (18.95-66.5 score)
|
43.41 Scores on a scale
Standard Deviation 12.577
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH(norm-based score), W6, n=7 (18.95-66.5 score)
|
44.17 Scores on a scale
Standard Deviation 11.666
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
GH(norm-based score), W12, n=6 (18.95-66.5 score)
|
43.20 Scores on a scale
Standard Deviation 7.655
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH(norm-based score), D1, n=7 (11.63-63.95 score)
|
43.56 Scores on a scale
Standard Deviation 11.237
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH(norm-based score), W6, n=7 (11.63-63.95 score)
|
47.81 Scores on a scale
Standard Deviation 10.704
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH(norm-based score), W12, n=6 (11.63-63.95 score)
|
48.63 Scores on a scale
Standard Deviation 6.002
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF(norm-based score), D1, n=7 (19.26-57.54 score)
|
39.41 Scores on a scale
Standard Deviation 10.256
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF(norm-based score), W6, n=7 (19.26-57.54 score)
|
40.52 Scores on a scale
Standard Deviation 9.410
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PF(norm-based score),W12, n=6 (19.26-57.54 score)
|
45.38 Scores on a scale
Standard Deviation 4.979
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE(norm-based score), D1, n=7 (14.39-56.17 score)
|
38.74 Scores on a scale
Standard Deviation 14.593
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE(norm-based score), W6, n=7 (14.39-56.17 score)
|
48.01 Scores on a scale
Standard Deviation 10.795
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RE(norm-based score), W12, n=6 (14.39-56.17 score)
|
44.19 Scores on a scale
Standard Deviation 7.635
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP(norm-based score), D1, n=7 (21.23-57.16 score)
|
42.34 Scores on a scale
Standard Deviation 10.614
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP(norm-based score), W6, n=7 (21.23-57.16 score)
|
45.48 Scores on a scale
Standard Deviation 8.308
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RP(norm-based score), W12, n=6 (21.23-57.16 score)
|
45.38 Scores on a scale
Standard Deviation 9.096
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF(norm-based score), D1, n=7 (17.23-57.34 score)
|
50.38 Scores on a scale
Standard Deviation 6.823
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF(norm-based score), W6, n=7 (17.23-57.34 score)
|
43.32 Scores on a scale
Standard Deviation 10.174
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF(norm-based score), W12,n=6 (17.23-57.34 score)
|
41.91 Scores on a scale
Standard Deviation 8.270
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT(norm-based score), D1, n=7 (22.89-70.4 score)
|
44.26 Scores on a scale
Standard Deviation 7.923
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT(norm-based score), W6, n=7 (22.89-70.4 score)
|
48.93 Scores on a scale
Standard Deviation 9.007
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
VT(norm-based score), W12, n=6 (22.89-70.4 score)
|
46.47 Scores on a scale
Standard Deviation 5.069
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PCS, D1, n=7 (5.02-79.78 score)
|
42.87 Scores on a scale
Standard Deviation 7.767
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PCS, W6, n=7 (5.02-79.78 score)
|
43.57 Scores on a scale
Standard Deviation 9.507
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
PCS, W12, n=6 (5.02-79.78 score)
|
43.74 Scores on a scale
Standard Deviation 6.743
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MCS, D1, n=7 (-3.33-80.09 score)
|
42.87 Scores on a scale
Standard Deviation 12.198
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MCS, W6, n=7 (-3.33-80.09 score)
|
50.81 Scores on a scale
Standard Deviation 9.652
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MCS, W12, n=6 (-3.33-80.09 score)
|
46.27 Scores on a scale
Standard Deviation 6.933
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RCI, D1, n=7 (0-15 score)
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RCI, W6, n=7 (0-15 score)
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
RCI, W12, n=6 (0-15 score)
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF-6D HUI Score, D1, n=7 (0-1 score)
|
0.64 Scores on a scale
Standard Deviation 0.114
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF-6D HUI Score, W6, n=7 (0-1 score)
|
0.70 Scores on a scale
Standard Deviation 0.114
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
SF-6D HUI Score, W12, n=6 (0-1 score)
|
0.64 Scores on a scale
Standard Deviation 0.051
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH Enhanced Score, D1, n=7 (0-63 score)
|
11.57 Scores on a scale
Standard Deviation 7.955
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH Enhanced Score, W6, n=7 (0-63 score)
|
8.62 Scores on a scale
Standard Deviation 7.459
|
|
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
MH Enhanced Score, W12, n=6 (0-63 score)
|
7.83 Scores on a scale
Standard Deviation 3.939
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Population: The Safety Population comprises of all participants who received at least one dose of study treatment. This population is based on the treatment the participant actually received.
The following laboratory parameters were analyzed: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, lymphocytes; alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), total bilirubin, albumin, total protein, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, calcium, total carbondioxide, glucose, magnesium, and ferritin. Only those parameters for which at least one value of clinical concern are reported in the table. Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
ALP, High
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
ALP, Low
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
ALT, High
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
ALT, Low
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
AST, High
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
AST, Low
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Calcium, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Calcium, Low
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Ferritin, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Ferrtin, Low
|
4 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
GGT, High
|
3 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
GGT, Low
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Glucose, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Glucose, Low
|
3 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Hemoglobin, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Hemoglobin, Low
|
4 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Hematocrit, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Hematocrit, Low
|
2 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Lymphocytes, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Lymphocytes, Low
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Platelet count, High
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Platelet count, Low
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Total Protein, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
Total Protein, Low
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
WBC, High
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
WBC, Low
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Population
The following laboratory parameters were analyzed in supine position after 10 minutes rest: Diastolic blood pressure (DBP), Systolic blood pressure (SBP) and Heart rate (HR). Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Anytime OT, High,n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Anytime OT, Low, n=7
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Day 1, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Day 1, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 3, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 3, Low, n=7
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 6, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 6, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 9, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 9, Low, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 12, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
DBP, Week 12, Low, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Anytime OT, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Anytime OT, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Day 1, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Day 1, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 3, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 3, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 6, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 6, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 9, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 9, Low, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 12, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
HR, Week 12, Low, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Anytime OT, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Anytime OT, Low, n=7
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Day 1, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Day 1, Low, n=7
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 3, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 3, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 6, High, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 6, Low, n=7
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 9, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 9, Low, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 12, High, n=6
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
SBP, Week 12, Low, n=6
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety population
The following ECG parameters were analyzed: PR, QRS, QT, corrected QT \[QTc\] intervals. Criteria for clinical concern:. QT where value is \> 450, QT\[QTc\] where value is \> 450, PR where value is \< 110 or \> 220, QRS where value is \< 75 or \>110.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Population
Protein - values of clinical concern if change from "trace" at baseline to 3+ any time on-therapy or from 0 at baseline to 2+ any time on-therapy.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks)Population: Safety Population
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)
Any AE
|
7 Participants
|
|
Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)
Serious AE
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 3, 6, 9 and 12Population: Pharmacokinetic Population: The Pharmacokinetic Population includes participants who had a pharmacokinetic sample obtained and analyzed. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
Predose (trough) blood samples were collected at weeks 3, 6, 9, and 12. Blood samples for pharmacokinetic (PK) profile were collected at pre-dose, 1, 2, 3, 4, 6 and 8 hours post dose. Area under the curve (0-tau), Concentration tau (Ctau), and maximum concentration (Cmax) following repeat administration was to be studied if data permitted.
Outcome measures
| Measure |
GW786034 50 mg Once Daily
n=7 Participants
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Plasma Concentration of GW786034 at the Indicated Time Points
Week 3, n=7
|
6.3 µg/mL
Standard Deviation 4.45
|
|
Plasma Concentration of GW786034 at the Indicated Time Points
Week 6, n=7
|
6.5 µg/mL
Standard Deviation 5.33
|
|
Plasma Concentration of GW786034 at the Indicated Time Points
Week 9, n=6
|
6.2 µg/mL
Standard Deviation 4.98
|
|
Plasma Concentration of GW786034 at the Indicated Time Points
Week 12, n=6
|
6.8 µg/mL
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: Weeks 3, 6, 9 and 12Population: Pharmacokinetic/Pharmacodynamic Population
Graphical exploration of PK/PD relationships between pazopanib exposure and selected parameters was to be explored if data permitted. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 3, 6, 9 and 12Population: Pharmacokinetic/Pharmacodynamic Population
A repeated categorical event per time interval PK/PD modeling analysis was planned (data permitting) to characterize the relationship between pazopanib trough concentrations and epistaxis frequency and duration/severity. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.
Outcome measures
Outcome data not reported
Adverse Events
GW786034 50 mg Once Daily
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GW786034 50 mg Once Daily
n=7 participants at risk
Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
|
|---|---|
|
Infections and infestations
Bronchitis
|
28.6%
2/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Infections and infestations
Otitis media
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Infections and infestations
Pharyngitis streptococcal
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Investigations
Weight decreased
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Injury, poisoning and procedural complications
Sunburn
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (12 weeks post-dose) to follow-up (assessed up to 28 weeks).
On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment and is based on the actual study treatment received.
|
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