Telangiectasia, Hereditary Hemorrhagic
Conditions
Keywords
Pazopanib, hereditary haemorrhagic telangiectasia, bleeding
Brief summary
This study will investigate whether pazopanib can reduce epistaxis and improve anaemia in subjects with hereditary haemorrhagic telangiectasia (HHT) at a dose that is well tolerated. The study will have 2 parts. Part A will be an open label, dose-escalation study in which up to 4 cohorts of approximately 6 subjects each will receive increasing doses of pazopanib for a maximum of 12 weeks. The dose in the first cohort will be 50mg per day and the maximum dose in a cohort will be 400 mg per day. Dose escalation will not occur as planned if the predefined safety stopping criteria are met or at least 4 subjects in a cohort have demonstrated efficacy (as measured by epistaxis, haemoglobin, transfusion or iron infusion requirements). If efficacy is demonstrated in Part A with an acceptable safety profile, Part B will be initiated to further define the optimal dose(s) including dose duration/schedule and to provide further support for the proof of mechanism. Approximately 15 subjects will participate and will be randomised to active or placebo in a ratio of 3:2. This part of the study will be double-blind.
Interventions
DRUGPazopanib
Pazopanib is available as 50 mg and 200 mg tablets to be administered orally once daily in the morning at least one hour before or two hours after a meal for 12 weeks
DRUGPlacebo
Pazopanib matching placebo is available as tablets to be administered orally once daily in the morning at least one hour before or two hours after a meal for 12 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males/females aged between 18 and 75 years of age inclusive, at the time of signing the informed consent. * Diagnosis of definite or possible HHT by the Curaçao criteria. According to the Curaçao criteria, a definite diagnosis of HHT is defined as having at least 3 of the following criteria while a possible diagnosis is defined as 2 criteria: a) spontaneous and recurrent epistaxis; b) multiple telangiectasias at characteristic sites: lips, oral cavity, fingers, nose; c) visceral lesions: gastrointestinal (GI) telangiectasia, pulmonary, hepatic, cerebral or spinal arteriovenous malformations (AVMs); d) a first degree relative with HHT according to these criteria. * Subject meets at least one of the following criteria: a) Severe epistaxis over previous 4 weeks defined as an average of at least 3 nose bleeds per week AND a total duration of greater than 15 min per week AND requiring iron therapy (oral and/or intravenous); b) Moderate or severe iron deficiency anaemia (Hgb \< 11gram \[g\]/deciliter \[dL\], at screening) despite iron infusions (at least 0.5g iron per month) or blood transfusions (at least 2 units per month) AND substantial compromise in the quality of life according to the investigator (e.g. nose bleeds, lethargic, cannot maintain job, listless, fatigue). Anaemia must be HHT related in the opinion of the investigator, ie: due to HHT-defined bleeding (epistaxis and/or bleeding from the GI tract \[presence of telangiectatic lesions, exclusion of active ulcer disease or other infection, inflammation\]), and lack of other known etiologies such as blood dyscrasias. * Epistaxis (if applicable) is considered to be clinically stable during the 4 weeks prior to Screening in the clinical judgment of the investigator (i.e. no major changes in frequency or duration of epistaxis). * A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy \[for this definition, documented refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\]; or postmenopausal defined as 12 months of spontaneous amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 milli-international units per milliliter (MIU/mL) and estradiol \< 40 picogram per milliliter (pg/mL) (\<147 picomole per liter \[pmol/L\]) is confirmatory\]. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Subject is able and willing to return for outpatient visits at the protocol specified intervals. * Subject agrees not to undergo laser ablation of nasal telangiectasias or take any experimental therapies for HHT other than the study drug while participating in the study (over the counter medications, topical treatments, nasal hygiene and palliative therapies are acceptable as long as use is consistent). If subjects stop taking experimental therapies on entry to the study there should be a wash-out period of at least 5 half-lives prior to the start of the run-in). * Based on averaged corrected QT either Bazett's formula (QTcB), Fridericia's formula (QTcF) values of triplicate ECGs obtained over a brief recording period: QTc \< 450 milliseconds (msec); or QTc \< 480 msec in subjects with Bundle Branch Block.
Exclusion criteria
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones; and with the exception of vascular abnormalities that are related to the HHT). * Subject has known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib that in the opinion of the investigator contradicts their participation. * Currently has untreated cerebral vascular malformations (CVMs) (Note: magnetic resonance imaging \[MRI\] scan does not need to be repeated at Screen if CVMs were absent on scan after age 18 years or in the last 5 years). * Currently has known pulmonary AVMs with feeding artery diameter \>3 millimeter (mm). * Symptomatic liver AVMs (defined as chronic right upper quadrant pain, symptomatic portal hypertension or heart failure). * Known significant bleeding sources other than nasal or gastrointestinal. * Systemic use of a vascular endothelial growth factor (VEGF) inhibitor in the past 12 weeks or previous enrolment in this study. * Current use of anticoagulants including but not limited to vitamin K antagonists (e.g., warfarin) at any dose; unfractionated or low molecular weight heparins at standard doses for treatment of venous thromboembolism (VTE) (e.g., enoxoparin); antiplatelets (e.g., clopidogrel), or direct factor Xa inhibitors (e.g., apixaban). Use of low dose aspirin \<= 81mg is allowed as long as use is consistent. * Active and recent onset diarrhoea. * Current or recent malignancies (except non-melanoma skin cancers) Subject has: a) had major surgery (eg, surgical ligation of an AVM) or trauma within 28 days; b) had minor surgical procedures (eg, central venous access line removal) within 7 days prior to dosing; c) any non-healing wound, fracture or ulcer * Subject has clinically significant gastrointestinal abnormalities (other than HHT-related vascular lesions) including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug (eg, short bowel syndrome), active peptic ulcer, known intraluminal metastatic lesions/s with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other gastrointestinal conditions with increased risk of perforation, lifetime history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess * Subject has a history of cerebrovascular accident (including transient ischaemic attacks), pulmonary embolism or untreated deep vein thrombosis (DVT) within the 6 months prior to first dose of study drug. * Subject has a history of any one or more of the following cardiovascular conditions within the 6 months prior to first dose of study drug: cardiac angioplasty or stenting, myocardial infarction, unstable angina, ischaemic stroke, symptomatic peripheral vascular disease * Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA). * A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. * Hgb \< 7 gram per deciliter (g/dL). * Platelets \< 100x10\^9/L, International normalized ratio (INR) \> 1.2x upper limit of normal (ULN) and activated partial thromboplastin time (aPTT) \>1.2xULN. * Alanine aminotransferese (ALT) \>= 2xULN or bilirubin \> 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). Subject has poorly controlled hypertension \[defined as systolic blood pressure (SBP) \>= 140 millimeter of mercury (mmHg) or diastolic blood pressure (DBP) \>= 90mmHg\]. Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. At Screening, blood pressure must be assessed three times and the mean SBP/DBP must be \<140/90 mmHg in order for a subject to be eligible for the study. * Substantive renal disease (estimated glomerular filtration rate \[eGFR\] \< 60 mL/minute/1.73 meter\^3 calculated using the Cockcroft-Gault formula) * Thyroid stimulating hormone \> ULN. * Urine protein creatinine ratio \>0.3 * White blood cell count\< 3500/mm\^3. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the start of the run-in period: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Unable or unwilling to discontinue use of prohibited medications mentioned below for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the start of the run-in period and for the duration of the study. Medications that inhibit Cytochrome P450 3A4 (CYP3A4) may result in increased plasma pazopanib concentrations; therefore, co-administration of strong CYP3A4 inhibitors is PROHIBITED beginning 14 days prior to the first dose of study treatment until 15 days after the last dose of pazopanib. Strong CYP3A4 inhibitors include (but are not limited to): Antibiotics: clarithromycin, telithromycin, troleandomycin; human immunodeficiency virus (HIV): protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir); Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole; Antidepressants: nefazodone, Miscellaneous: grapefruit, grapefruit juice or other grapefruit product. statins, anticoagulants and tamoxifen use is prohibited.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28 | 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). |
| Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12) | Baseline, Week 9, Week 10.5 and Week 12 | 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. |
| Change From Baseline in Hemoglobin at the Indicated Time Points | 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 28 | 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). |
| 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) | Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries) | 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. |
| 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) | Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries) | 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. |
| 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) | Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries) | 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. |
| Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Last 4 weeks of run-in and during last 4 weeks of dosing period | 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. |
| Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Last 4 weeks of run-in and during last 4 weeks of dosing period | 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. |
| Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval | Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graphical Exploration of PK/Pharmacodynamic (PD) Relationships Between Pazopanib Exposure and Selected PD | Weeks 3, 6, 9 and 12 | 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. |
| Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12) | Baseline, Week 9, Week 10.5 and Week 12 | 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. |
| PK/PD Modeling Analysis to Characterize the Relationship Between Pazopanib Trough Concentrations and Epistaxis Frequency and Duration/Severity | Weeks 3, 6, 9 and 12 | 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. |
| Change From Baseline in Ferritin at the Indicated Time Points | 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 28 | 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). |
| Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12 | Day (D) 1, Week (W) 6 and Week 12 | 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). |
| Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Up to Week 16 | 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. |
| Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | Up to Week 16 | 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. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern | Up to Week 16 | 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. |
| Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern | Up to Week 16 | 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. |
| Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE) | From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks) | 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. |
| Plasma Concentration of GW786034 at the Indicated Time Points | Weeks 3, 6, 9 and 12 | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | GW786034 50 mg Once Daily |
|---|---|
| Age, Continuous | 57.3 Years STANDARD_DEVIATION 9.14 |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Change From Baseline in Epistaxis Severity Score at the Indicated Time Points
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).
Time frame: Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Week 6, n=7 | -0.59 Scores on a scale | Standard Deviation 0.802 |
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Week 12, n=6 | -1.16 Scores on a scale | Standard Deviation 1.023 |
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Follow-up Week 16, n=7 | -0.60 Scores on a scale | Standard Deviation 1.299 |
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Follow-up Week 20, n=6 | -1.41 Scores on a scale | Standard Deviation 1.674 |
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Follow-up Week 24, n=5 | -1.27 Scores on a scale | Standard Deviation 1.519 |
| GW786034 50 mg Once Daily | Change From Baseline in Epistaxis Severity Score at the Indicated Time Points | Follow-up Week 28, n=5 | -0.08 Scores on a scale | Standard Deviation 1.92 |
Primary
Change From Baseline in Hemoglobin at the Indicated Time Points
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).
Time frame: 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 28
Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 1.5, n=7 | 7.50 g/L | Standard Deviation 11.113 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 3, n=6 | 11.92 g/L | Standard Deviation 13.492 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 4.5, n=7 | 7.50 g/L | Standard Deviation 22.042 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 6, n=7 | 6.48 g/L | Standard Deviation 19.967 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 7.5, n=6 | 8.83 g/L | Standard Deviation 12.77 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 9, n=6 | 6.67 g/L | Standard Deviation 14.865 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 10.5, n=6 | 7.50 g/L | Standard Deviation 15.485 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Week 12, n=6 | 8.58 g/L | Standard Deviation 25.15 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Follow-Up Week 16, n=7 | 7.00 g/L | Standard Deviation 22.739 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Follow-Up Week 20, n=6 | 7.56 g/L | Standard Deviation 19.212 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Follow-Up Week 24, n=5 | 4.93 g/L | Standard Deviation 11.086 |
| GW786034 50 mg Once Daily | Change From Baseline in Hemoglobin at the Indicated Time Points | Follow-Up Week 28, n=5 | -3.80 g/L | Standard Deviation 7.926 |
Primary
Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)
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.
Time frame: Baseline, Week 9, Week 10.5 and Week 12
Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW786034 50 mg Once Daily | Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12) | 7.58 Grams per liter (g/L) | Standard Deviation 17.543 |
Primary
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)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | 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 | 26 Minutes |
| GW786034 50 mg Once Daily | 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 | 28 Minutes |
| GW786034 50 mg Once Daily | 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 | 32 Minutes |
| GW786034 50 mg Once Daily | 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 | 32 Minutes |
| GW786034 50 mg Once Daily | 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 | 34 Minutes |
| GW786034 50 mg Once Daily | 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 | 26 Minutes |
| GW786034 50 mg Once Daily | 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 | 30 Minutes |
| GW786034 50 mg Once Daily | 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 | 22 Minutes |
| GW786034 50 mg Once Daily | 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 | 28 Minutes |
| GW786034 50 mg Once Daily | 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 | 34 Minutes |
| GW786034 50 mg Once Daily | 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 | 43 Minutes |
| GW786034 50 mg Once Daily | 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 | 33 Minutes |
| GW786034 50 mg Once Daily | 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 | 27 Minutes |
| GW786034 50 mg Once Daily | 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 | 46 Minutes |
| GW786034 50 mg Once Daily | 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 | 66 Minutes |
| GW786034 50 mg Once Daily | 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 | 846 Minutes |
| GW786034 50 mg Once Daily | 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 | 301 Minutes |
| GW786034 50 mg Once Daily | 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 | 966 Minutes |
| GW786034 50 mg Once Daily | 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 | 1288 Minutes |
| GW786034 50 mg Once Daily | 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 | 980 Minutes |
| GW786034 50 mg Once Daily | 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 | 589 Minutes |
| GW786034 50 mg Once Daily | 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 | 594 Minutes |
| GW786034 50 mg Once Daily | 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 | 386 Minutes |
| GW786034 50 mg Once Daily | 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 | 240 Minutes |
| GW786034 50 mg Once Daily | 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 | 191 Minutes |
| GW786034 50 mg Once Daily | 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 | 426 Minutes |
| GW786034 50 mg Once Daily | 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 | 261 Minutes |
| GW786034 50 mg Once Daily | 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 | 236 Minutes |
| GW786034 50 mg Once Daily | 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 | 115 Minutes |
| GW786034 50 mg Once Daily | 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 | 467 Minutes |
| GW786034 50 mg Once Daily | 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 | 14 Minutes |
| GW786034 50 mg Once Daily | 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 | 130 Minutes |
| GW786034 50 mg Once Daily | 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 | 210 Minutes |
| GW786034 50 mg Once Daily | 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 | 132 Minutes |
| GW786034 50 mg Once Daily | 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 | 118 Minutes |
| GW786034 50 mg Once Daily | 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 | 84 Minutes |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 68 Minutes |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 46 Minutes |
| GW786034 50 mg Once Daily | 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 | 5 Minutes |
| GW786034 50 mg Once Daily | 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 | 269 Minutes |
| GW786034 50 mg Once Daily | 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 | 30 Minutes |
| GW786034 50 mg Once Daily | 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 | 312 Minutes |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 140 Minutes |
| GW786034 50 mg Once Daily | 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 | 79 Minutes |
| GW786034 50 mg Once Daily | 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 | 104 Minutes |
| GW786034 50 mg Once Daily | 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 | 165 Minutes |
| GW786034 50 mg Once Daily | 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 | 127 Minutes |
| GW786034 50 mg Once Daily | 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 | 361 Minutes |
| GW786034 50 mg Once Daily | 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 | 63 Minutes |
| GW786034 50 mg Once Daily | 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 | 378 Minutes |
| GW786034 50 mg Once Daily | 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 | 404 Minutes |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 151 Minutes |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 170 Minutes |
| GW786034 50 mg Once Daily | 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 | 176 Minutes |
| GW786034 50 mg Once Daily | 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 | 253 Minutes |
| GW786034 50 mg Once Daily | 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 | 94 Minutes |
| GW786034 50 mg Once Daily | 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 | 26 Minutes |
| GW786034 50 mg Once Daily | 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 | 0 Minutes |
| GW786034 50 mg Once Daily | 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 | 12 Minutes |
| GW786034 50 mg Once Daily | 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 | 28 Minutes |
| GW786034 50 mg Once Daily | 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 | 19 Minutes |
| GW786034 50 mg Once Daily | 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 | 19 Minutes |
| GW786034 50 mg Once Daily | 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 | 15 Minutes |
| GW786034 50 mg Once Daily | 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 | 8 Minutes |
| GW786034 50 mg Once Daily | 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 | 26 Minutes |
| GW786034 50 mg Once Daily | 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 | 213 Minutes |
| GW786034 50 mg Once Daily | 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 | 190 Minutes |
| GW786034 50 mg Once Daily | 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 | 58 Minutes |
| GW786034 50 mg Once Daily | 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 | 110 Minutes |
| GW786034 50 mg Once Daily | 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 | 15 Minutes |
| GW786034 50 mg Once Daily | 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 | 36 Minutes |
| GW786034 50 mg Once Daily | 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 | 53 Minutes |
| GW786034 50 mg Once Daily | 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 | 40 Minutes |
| GW786034 50 mg Once Daily | 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 | 114 Minutes |
| GW786034 50 mg Once Daily | 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 | 68 Minutes |
| GW786034 50 mg Once Daily | 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 | 87 Minutes |
Primary
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)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 23 Number of nosebleeds |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 20 Number of nosebleeds |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 | 3 Number of nosebleeds |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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
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)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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
Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval
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.
Time frame: Last 4 weeks of run-in and during last 4 weeks of dosing period
Population: Pharmacodynamic Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Dosing period, Day 57 - 84 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Follow up, Day 1 - 28 | 3000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Baseline | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Dosing period, Day 1 - 27 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Dosing period, Day 28 - 55 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Dosing period, Day 56 - 83 | 600 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Follow up, Day 1 - 28 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Follow up, Day 29 - 56 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Follow up, Day 57 - 84 | 600 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 1, Follow up, Day 85 - 112 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Baseline | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Dosing period, Day 1 - 5 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Dosing period, Day 6 - 33 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Dosing period, Day 34 - 61 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Dosing period, Day 62 - 89 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Follow up, Day 1 - 28 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Follow up, Day 29 - 56 | 500 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Follow up, Day 57 - 84 | 1500 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 2, Follow up, Day 85 - 106 | 500 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Baseline | 3000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Dosing period, Day 1 - 28 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Dosing period, Day 29 - 56 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Follow up, Day 29 - 56 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Follow up, Day 57 - 84 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Follow up, Day 85 - 112 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 3, Follow up, Day 113 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Baseline | 800 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Dosing period, Day 1 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Dosing period, Day 2 - 29 | 800 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Dosing period, Day 30 - 57 | 400 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Dosing period, Day 58 - 85 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Follow up, Day 1 - 28 | 100 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Follow up, Day 29 - 56 | 200 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Follow up, Day 57 - 84 | 200 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Follow up, Day 85 - 112 | 200 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 4, Follow up, Day 113 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Baseline | 750 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Dosing period, Day 1 - 2 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Dosing period, Day 3 - 30 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Dosing period, Day 31 - 58 | 1500 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Dosing period, Day 59 - 86 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Follow up, Day 1 - 28 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Follow up, Day 29 - 56 | 750 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Follow up, Day 57 - 84 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Follow up, Day 85 - 112 | 750 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 5, Follow up, Day 113 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 6, Baseline | 4150 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 6, Dosing period, Day 1 - 15 | 2460 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 6, Dosing period, Day 16 - 43 | 3640 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 6, Follow up, Day 1 - 28 | 3640 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 6, Follow up, Day 29 - 56 | 4660 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 7, Baseline | 510 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 7, Dosing period, Day 1 - 28 | 510 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 7, Dosing period, Day 29 - 56 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Dosing period, Day 57 - 84 | 1020 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval | Participant 7, Follow up, Day 1 - 28 | 0 Milligram |
| GW786034 50 mg Once Daily | 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
Total Iron Intake Over the Last 4 Weeks of the Dosing Period
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.
Time frame: Last 4 weeks of run-in and during last 4 weeks of dosing period
Population: Pharmacodynamic Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 4, Dosing period, Day 2 - 29 | 800 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 4, Dosing period, Day 30 - 57 | 400 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 1, Dosing period, Day 56 - 83 | 600 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 1, Dosing period, Day 28 - 55 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 1, Baseline | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 1, Dosing period, Day 1 - 27 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 2, Baseline | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 2, Dosing period, Day 1 - 5 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 2, Dosing period, Day 6 - 33 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 2, Dosing period, Day 34 - 61 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 2, Dosing period, Day 62 - 89 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 3, Baseline | 3000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 3, Dosing period, Day 1 - 28 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 3, Dosing period, Day 29 - 56 | 1000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 3, Dosing period, Day 57 - 84 | 2000 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 4, Baseline | 800 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 4, Dosing period, Day 1 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 4, Dosing period, Day 58 - 85 | 300 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 5, Baseline | 750 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 5, Dosing period, Day 1 - 2 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 5, Dosing period, Day 3 - 30 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 5, Dosing period, Day 31 - 58 | 1500 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 5, Dosing period, Day 59 - 86 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 6, Baseline | 4150 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 6, Dosing period, Day 1 - 15 | 2460 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 6, Dosing period, Day 16 - 43 | 3640 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 7, Baseline | 510 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 7, Dosing period, Day 1 - 28 | 510 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 7, Dosing period, Day 29 - 56 | 0 Milligram |
| GW786034 50 mg Once Daily | Total Iron Intake Over the Last 4 Weeks of the Dosing Period | Participant 7, Dosing period, Day 57 - 84 | 1020 Milligram |
Primary
Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval
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.
Time frame: Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-up
Population: Pharmacodynamic Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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
Change From Baseline in Ferritin at the Indicated Time Points
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).
Time frame: 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 28
Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 1.5, n=4 | -73.75 µg per L | Standard Deviation 223.827 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 3, n=6 | -59.33 µg per L | Standard Deviation 182.538 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 4.5, n=5 | -118.30 µg per L | Standard Deviation 184.946 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 6, n=7 | 7.07 µg per L | Standard Deviation 62.727 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 7.5, n=2 | -31.75 µg per L | Standard Deviation 67.529 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 9, n=6 | -48.83 µg per L | Standard Deviation 86.762 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 10.5, n=5 | -82.90 µg per L | Standard Deviation 127.769 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Week 12, n=3 | -111.67 µg per L | Standard Deviation 231.107 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | Change From Baseline in Ferritin at the Indicated Time Points | Follow-Up Week 28, n=5 | 1.90 µg per L | Standard Deviation 82.75 |
Secondary
Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)
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.
Time frame: Baseline, Week 9, Week 10.5 and Week 12
Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW786034 50 mg Once Daily | 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
Graphical Exploration of PK/Pharmacodynamic (PD) Relationships Between Pazopanib Exposure and Selected PD
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.
Time frame: Weeks 3, 6, 9 and 12
Population: Pharmacokinetic/Pharmacodynamic Population
Secondary
Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)
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.
Time frame: From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE) | Any AE | 7 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE) | Serious AE | 0 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern
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.
Time frame: Up to Week 16
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW786034 50 mg Once Daily | Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern | 1 Participants |
Secondary
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern
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.
Time frame: Up to Week 16
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Lymphocytes, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Total Protein, Low | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | WBC, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Hemoglobin, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | ALP, High | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | ALP, Low | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | ALT, High | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | ALT, Low | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | AST, High | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | AST, Low | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Calcium, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Calcium, Low | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Ferritin, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Ferrtin, Low | 4 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | GGT, High | 3 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | GGT, Low | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Glucose, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Glucose, Low | 3 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Hemoglobin, Low | 4 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Hematocrit, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Hematocrit, Low | 2 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Lymphocytes, Low | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Platelet count, High | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Platelet count, Low | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | Total Protein, High | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern | WBC, Low | 3 Participants |
Secondary
Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern
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.
Time frame: Up to Week 16
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW786034 50 mg Once Daily | Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern | 0 Participants |
Secondary
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
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.
Time frame: Up to Week 16
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Anytime OT, High,n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 6, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 12, Low, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Anytime OT, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Anytime OT, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Day 1, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Day 1, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 6, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 9, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Day 1, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Day 1, Low, n=7 | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Anytime OT, Low, n=7 | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Day 1, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Day 1, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 3, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 3, Low, n=7 | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 6, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 9, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 9, Low, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | DBP, Week 12, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 3, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 3, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 6, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 9, Low, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 12, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | HR, Week 12, Low, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Anytime OT, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Anytime OT, Low, n=7 | 1 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 3, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 3, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 6, High, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 6, Low, n=7 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 9, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 9, Low, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 12, High, n=6 | 0 Participants |
| GW786034 50 mg Once Daily | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | SBP, Week 12, Low, n=6 | 0 Participants |
Secondary
Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12
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).
Time frame: Day (D) 1, Week (W) 6 and Week 12
Population: Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 26.59 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 23.57 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 25.82 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 9.41 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 8.27 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 28.51 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
| GW786034 50 mg Once Daily | 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 |
Secondary
PK/PD Modeling Analysis to Characterize the Relationship Between Pazopanib Trough Concentrations and Epistaxis Frequency and Duration/Severity
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.
Time frame: Weeks 3, 6, 9 and 12
Population: Pharmacokinetic/Pharmacodynamic Population
Secondary
Plasma Concentration of GW786034 at the Indicated Time Points
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.
Time frame: Weeks 3, 6, 9 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW786034 50 mg Once Daily | Plasma Concentration of GW786034 at the Indicated Time Points | Week 3, n=7 | 6.3 µg/mL | Standard Deviation 4.45 |
| GW786034 50 mg Once Daily | Plasma Concentration of GW786034 at the Indicated Time Points | Week 6, n=7 | 6.5 µg/mL | Standard Deviation 5.33 |
| GW786034 50 mg Once Daily | Plasma Concentration of GW786034 at the Indicated Time Points | Week 9, n=6 | 6.2 µg/mL | Standard Deviation 4.98 |
| GW786034 50 mg Once Daily | Plasma Concentration of GW786034 at the Indicated Time Points | Week 12, n=6 | 6.8 µg/mL | Standard Deviation 6.85 |