Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000 /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate to a higher rate of sustained viral response.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB-497115-GR | Experimental | investigational product for thrombocytopenia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-497115-GR | Drug | TPO receptor agonist to increase platelet count |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1 | Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw. | From Baseline up to Week 9 in Part 1 |
| Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2 | Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2. Platelet counts were measured by blood draw. | From Antiviral Baseline to up to Week 48 in Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Platelet Count at the Indicated Time Points in Part 1 | Platelet counts were measured by blood draw | Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 |
| Time in Weeks to Achieve Platelet Count >= 100 Gi/L |
Not provided
Inclusion Criteria:
Subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned, as well as provided a written consent.
Female subject with non-childbearing potential [i.e., physiologically incapable of becoming pregnant, who: has had a hysterectomy, or had a bilateral oophorectomy (ovariectomy), or had a bilateral tubal ligation, or is post-menopausal for greater than one year].
Female subject with childbearing potential, has a negative urine or serum pregnancy test at screening and within the 24-hour period prior to the first dose of SB-497115-GR, and completely abstains from intercourse or agree to use two of the following acceptable methods of contraception for 14 days before exposure to SB-497115-GR, throughout the clinical trial, and for 24 weeks after completion or premature discontinuation from the study.
Intrauterine device or intrauterine system that meets the effectiveness criteria as stated in the product label.
Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
Double-barrier contraception (condom with spermicidal jelly, or diaphragm with spermicide).
Male subject with childbearing potential partner completely abstains from intercourse or agree to use condom and diaphragm with spermicide.
Items Values Platelet <80,000 /μL Haemoglobin ≥12.0 g/dL* Absolute neutrophil count (ANC) ≥1500 /μL* Creatinine clearance >50 mL/minute Total bilirubin <2.0 mg/dL Albumin >3.0 g/dL Prothrombin time >60%
*If the investigators consider the values are sufficient to give Peg-IFN/RBV, then a subject can be enrolled upon consulting the Medical Monitor.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 467-8602 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31258695 | Derived | Kawaguchi T, Komori A, Fujisaki K, Nishiguchi S, Kato M, Takagi H, Tanaka Y, Notsumata K, Mita E, Nomura H, Shibatoge M, Takaguchi K, Hattori T, Sata M, Koike K. Eltrombopag enables initiation and completion of pegylated interferon/ribavirin therapy in Japanese HCV-infected patients with chronic liver disease and thrombocytopenia. Exp Ther Med. 2019 Jul;18(1):596-604. doi: 10.3892/etm.2019.7616. Epub 2019 May 24. |
Not provided
Not provided
The total study duration was a maximum of 88 weeks, which consisted of a Screening Period of less than or equal to 45 days, the Pre-Antiviral Treatment Period (Part 1) from 1 up to 9 weeks and the Antiviral Treatment Period (Part 2) of 48 weeks and Follow-up Period of 24 weeks.
Participants with chronic hepatitis C (CHC) or compensated liver cirrhosis, who cannot start polyethylene glycol (Peg)-interferon (IFN)/ribavirin (RBV) therapy due to thrombocytopenia (platelet count <80 giga (10^9) cells per liter (Gi/L).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag Dose Escalation: Part 1 | Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period. |
| FG001 | Eltrombopag + Antiviral Therapy: Part 2 | Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count. |
| FG002 | Eltrombopag + Antiviral Therapy: Follow-up Period After Part | Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Antiviral Treatment Period (Part 1) |
|
| |||||||||||||||||||||
| Antiviral Treatment Period (Part 2) |
| ||||||||||||||||||||||
| Follow-up Period After Part 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag Dose Escalation: Part 1 | Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1 | Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw. | Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1. | Posted | Number | Participants | From Baseline up to Week 9 in Part 1 |
|
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eltrombopag Dose Escalation: Part 1 | Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver injury | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.
| From Baseline up to Week 9 in Part 1 |
| Median Platelet Count at the Indicated Time Points in Part 2 | Platelet counts were measured by blood draw | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | Platelet counts were measured by blood draw at specified timepoints. | Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2 |
| Minimum Platelet Count on Antiviral Therapy | Participants were assessed for platelet counts during antiviral therapy in Part 2. Platelet counts were measured by blood draw. | From Antiviral Baseline to up to Week 48 in Part 2 |
| Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw. | From Baseline up to Week 9 in Part 1 |
| Number of Antiviral Therapy Dose Reductions in Part 2 | Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV | From Antiviral Baseline up to Week 48 in Part 2 |
| Time to First Dose Reduction of Antiviral Therapy in Part 2 | Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Who Discontinued Antiviral Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Achieving Adherence to Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With Sustained Virologic Response (SVR) in Part 2 | Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2 | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2 | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2 | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2 | ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment. | From Antiviral Baseline up to Week 48 in Part 2 |
| Mean Serum HCV RNA at the Indicated Time Points In Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal. | Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2 |
| Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2 | FU Baseline, FU Week 12 and FU Week 24 after Part 2 |
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | From Baseline up to week 9 in Part 1 |
| Number of Participants With Any AE and Any SAE in Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | From Antiviral Baseline up to Week 48 in Part 2 |
| Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | From FU Baseline up to FU Week 24 after Part 2 |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24 |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
| Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
| Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline. | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | The heart rate was measured in participants at the indicated time points. | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
| Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
| Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | The weight of participants was recorded at the indicated time points. | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
| Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
| Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | The Body temperature of participants was recorded at the indicated time points.. | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
| Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
| Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
| Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Baseline up to Week 9 |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Antiviral Baseline up to Week 48 |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From FU Week 4 to FU Week 24 |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Baseline up to Week 9 |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From Antiviral Baseline up to Week 48 |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | From FU Week 4 to FU Week 24 |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24 |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | FU Baseline and FU Week 24 |
| Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal |
| Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | FU Baseline and FU Week 24 |
| Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). | Baseline; Week 24, Week 48, Withdrawal/Completion |
| Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). | FU Week 24 |
| Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). | Baseline; Week 24, Week 48, Withdrawal/Completion |
| Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). | FU Week 24 |
| Fukui |
| 918-8503 |
| Japan |
| GSK Investigational Site | Fukuoka | 803-8505 | Japan |
| GSK Investigational Site | Fukuoka | 830-0011 | Japan |
| GSK Investigational Site | Gunma | 370-0829 | Japan |
| GSK Investigational Site | Hyōgo | 663-8501 | Japan |
| GSK Investigational Site | Ibaraki | 317-0077 | Japan |
| GSK Investigational Site | Kagawa | 760-0017 | Japan |
| GSK Investigational Site | Kagawa | 760-8557 | Japan |
| GSK Investigational Site | Kagoshima | 899-5112 | Japan |
| GSK Investigational Site | Kanagawa | 213-8587 | Japan |
| GSK Investigational Site | Nagasaki | 856-8562 | Japan |
| GSK Investigational Site | Osaka | 540-0006 | Japan |
| GSK Investigational Site | Ōita | 879-5593 | Japan |
| GSK Investigational Site | Tokyo | 105-8470 | Japan |
| GSK Investigational Site | Wakayama | 646-8558 | Japan |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Diagnosis | Number | Participants |
|
| HCV genotype | Number | Participants |
|
| Child-Pugh Class | The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe) is calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5-6 = Class A (mild); 7-9 = Class B (moderate); >9 = Class C (severe). | Number | Participants |
|
| Number of Participants with or without previous IFN use | Number | Participants |
|
| Baseline alanine transaminase (ALT) | Mean | Standard Deviation | IU/L |
|
| Baseline Hepatitis C Virus (HCV) RNA | Mean | Standard Deviation | Log IU/mL |
|
| Baseline platelet counts | Number | Participants |
|
|
|
| Primary | Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2 | Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2. Platelet counts were measured by blood draw. | Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2. | Posted | Number | Participants | From Antiviral Baseline to up to Week 48 in Part 2 |
|
|
|
|
| Secondary | Median Platelet Count at the Indicated Time Points in Part 1 | Platelet counts were measured by blood draw | FAS1 Population. | Posted | Median | Full Range | 10^9 Cells Per Liter (Gi/L) | Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 |
|
|
|
| Secondary | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw. | FAS1 Population: all participants enrolled in Part 1. | Posted | Number | Participants | From Baseline up to Week 9 in Part 1 |
|
|
|
| Secondary | Median Platelet Count at the Indicated Time Points in Part 2 | Platelet counts were measured by blood draw | FAS2 Population. | Posted | Median | Full Range | Gi/L | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | Platelet counts were measured by blood draw at specified timepoints. | FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis. | Posted | Median | Full Range | Gi/L | Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2 |
|
|
|
| Secondary | Minimum Platelet Count on Antiviral Therapy | Participants were assessed for platelet counts during antiviral therapy in Part 2. Platelet counts were measured by blood draw. | FAS2 Population: all participants enrolled in Part 2. | Posted | Number | Participants | From Antiviral Baseline to up to Week 48 in Part 2 |
|
|
|
| Secondary | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw. | FAS1 Population: all participants enrolled in Part 1. | Posted | Number | Participants | From Baseline up to Week 9 in Part 1 |
|
|
|
| Secondary | Number of Antiviral Therapy Dose Reductions in Part 2 | Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV. | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. | FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. | FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Time to First Dose Reduction of Antiviral Therapy in Part 2 | Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction. | FAS2 Population. | Posted | Mean | Standard Deviation | weeks | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Who Discontinued Antiviral Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2 | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2 | FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2 | FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Achieving Adherence to Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. | FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. | FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With Sustained Virologic Response (SVR) in Part 2 | Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2 | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2 | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment. | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2 | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment. | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2 | ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment. | FAS2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal. | FAS2 Population. | Posted | Mean | Standard Deviation | Log international unit per milliliter | Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2 | FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis. | Posted | Mean | Standard Deviation | Log international unit per milliliter | FU Baseline, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag. | Posted | Number | Participants | From Baseline up to week 9 in Part 1 |
|
|
|
| Secondary | Number of Participants With Any AE and Any SAE in Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 in Part 2 |
|
|
|
| Secondary | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. | SP2 Population | Posted | Number | Participants | From FU Baseline up to FU Week 24 after Part 2 |
|
|
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | SP1 | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag. | Posted | Mean | Standard Deviation | mmHg | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. | SP2 Population. | Posted | Mean | Standard Deviation | mmHg | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | SP1 Population. | Posted | Mean | Standard Deviation | Beats per minute (bpm) | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
|
|
|
| Secondary | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline. | SP2 Population. | Posted | Mean | Standard Deviation | bpm | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | The heart rate was measured in participants at the indicated time points. | SP2 Population. | Posted | Mean | Standard Deviation | bpm | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | SP1 Population. | Posted | Mean | Standard Deviation | Kilogram (kg) | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | SP2 Population. | Posted | Mean | Standard Deviation | kg | Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | The weight of participants was recorded at the indicated time points. | SP2 Population | Posted | Mean | Standard Deviation | kg | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. | SP1 Population. | Posted | Mean | Standard Deviation | Degrees centigrade | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | SP2 Population. | Posted | Mean | Standard Deviation | Degrees centigrade | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | The Body temperature of participants was recorded at the indicated time points.. | SP2 Population | Posted | Mean | Standard Deviation | Degrees centigrade | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | SP1 Population. | Posted | Mean | Standard Deviation | kilogram per meters squared (kg/m^2) | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline | SP2 Population. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 |
|
|
|
| Secondary | Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. | SP2 Population | Posted | Mean | Standard Deviation | kilogram per meters squared (kg/m^2) | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 |
|
|
|
| Secondary | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP1 Population. | Posted | Number | Participants | From Baseline up to Week 9 |
|
|
|
| Secondary | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 |
|
|
|
| Secondary | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP2 Population. | Posted | Number | Participants | From FU Week 4 to FU Week 24 |
|
|
|
| Secondary | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP1 Population. | Posted | Number | Participants | From Baseline up to Week 9 |
|
|
|
| Secondary | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP2 Population. | Posted | Number | Participants | From Antiviral Baseline up to Week 48 |
|
|
|
| Secondary | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. | SP2 Population, | Posted | Number | Participants | From FU Week 4 to FU Week 24 |
|
|
|
| Secondary | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | SP1 Population. | Posted | Number | Participants | Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24 |
|
|
|
| Secondary | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | SP2 Population. | Posted | Number | Participants | Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal |
|
|
|
| Secondary | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. | SP2 Population. | Posted | Number | Participants | FU Baseline and FU Week 24 |
|
|
|
| Secondary | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | SP1 Population. | Posted | Number | Participants | Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal |
|
|
|
| Secondary | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. | SP2 Population. | Posted | Number | Participants | FU Baseline and FU Week 24 |
|
|
|
| Secondary | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). | SP1 Population. Only those participants available at the specified time points were analyzed (n=X). | Posted | Number | Participants | Baseline; Week 24, Week 48, Withdrawal/Completion |
|
|
|
| Secondary | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). | SP2 Population. | Posted | Number | Participants | FU Week 24 |
|
|
|
| Secondary | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). | SP1 Population. Only those participants available at the specified time points were analyzed (n=X). | Posted | Mean | Standard Deviation | Centimeters (cm) | Baseline; Week 24, Week 48, Withdrawal/Completion |
|
|
|
| Secondary | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). | SP2 Population. | Posted | Mean | Standard Deviation | Cm | FU Week 24 |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Eltrombopag + Antiviral Therapy: Part 2 | Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count. | 3 | 41 | 41 | 41 |
| EG002 | Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2 | Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment. | 4 | 41 | 6 | 41 |
| Myeloblast percentage increased | Investigations | MedDRA | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal exudates | Eye disorders | MedDRA | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| Title | Measurements |
|---|---|
|
| Week 3, n=17 |
|
| Week 4, n=9 |
|
| Week 5, n=4 |
|
| Week 6, n=3 |
|
| Week 7, n=3 |
|
| Week 8, n=2 |
|
| Week 9, n=1 |
|
| Withdrawal, n=4 |
|
| Title | Measurements |
|---|---|
|
| Within 8 Weeks |
|
| Within 9 Weeks |
|
| Greater than 9 Weeks |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=37 |
|
| Week 6, n=36 |
|
| Week 8, n=36 |
|
| Week 12, n=36 |
|
| Week 16, n=36 |
|
| Week 20, n=36 |
|
| Week 24, n=36 |
|
| Week 28, n=34 |
|
| Week 32, n=34 |
|
| Week 36, n=34 |
|
| Week 40, n=33 |
|
| Week 44, n=31 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, n=31 |
|
| Title | Measurements |
|---|---|
|
| >=100 to <150 Gi/L |
|
| >=150 to <200 Gi/L |
|
| >=200 to <400 Gi/L |
|
| >= 400 Gi/L |
|
| Title | Measurements |
|---|---|
|
| Eltrombopag 37.5 mg |
|
| Eltrombopag 50 mg |
|
| Did not initiate antiviral therapy |
|
| Title | Measurements |
|---|
|
| 3 DR |
|
| 4 DR |
|
| 5 DR |
|
| 7 DR |
|
| 8 DR |
|
| 10 DR |
|
| Title | Measurements |
|---|
|
| 3 DR |
|
| >3 DR |
|
| Title | Measurements |
|---|
|
| 3 DR |
|
| >3 DR |
|
| Title | Measurements |
|---|
|
| 3 DR |
|
| >3 DR |
|
|
| Title | Measurements |
|---|---|
|
| Week 12, n=36 |
|
| Week 24, n=36 |
|
| Week 36, n=34 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Drug-related AE |
|
| AE leading to withdrawal |
|
| SAE leading to withdrawal |
|
| On-going AE at the endo of study/withdrawal |
|
| Title | Measurements |
|---|
|
| Drug-related AE |
|
| AE leading to withdrawal |
|
| SAE leading to withdrawal |
|
| On-going AE at the end of study/withdrawal |
|
| Title | Measurements |
|---|
|
| Drug-related AE |
|
| AE leading to withdrawal |
|
| SAE leading to withdrawal |
|
| On-going AE at the end of study/withdrawal |
|
| Title | Measurements |
|---|---|
|
| SBP, Week 4, n=6 |
|
| SBP, Week 5, n=3 |
|
| SBP, Week 6, n=3 |
|
| SBP, Week 7, n=3 |
|
| SBP, Week 8, n=2 |
|
| SBP, Week 9, n=1 |
|
| SBP, Withdrawal, n=4 |
|
| SBP, Follow Up, week 4, n=3 |
|
| SBP, Follow Up, week 12, n=3 |
|
| SBP, Follow Up, week 24, n=3 |
|
| DBP, Week 1, n=38 |
|
| DBP, Week 2, n=30 |
|
| DBP, Week 3, n=11 |
|
| DBP, Week 4, n=6 |
|
| DBP, Week 5, n=3 |
|
| DBP, Week 6, n=3 |
|
| DBP, Week 7, n=3 |
|
| DBP, Week 8, n=2 |
|
| DBP, Week 9, n=1 |
|
| DBP, Withdrawal, n=4 |
|
| DBP, FU Week 4, n=3 |
|
| DBP, FU Week 12, n=3 |
|
| DBP, FU Week 24, n=3 |
|
| Title | Measurements |
|---|---|
|
| SBP, Week 4, n=37 |
|
| SBP, Week 6, n=36 |
|
| SBP, Week 8, n=36 |
|
| SBP, Week 12, n=36 |
|
| SBP, Week 16, n=36 |
|
| SBP, Week 20, n=36 |
|
| SBP, Week 24, n=36 |
|
| SBP, Week 28, n=34 |
|
| SBP, Week 32, n=34 |
|
| SBP, Week 36, n=34 |
|
| SBP, Week 40, n=33 |
|
| SBP, Week 44, n=31 |
|
| SBP, Week 48, n=31 |
|
| SBP, withdrawal, n=10 |
|
| DBP, Antiviral Baseline, n=40 |
|
| DBP, Week 1, n=40 |
|
| DBP, Week 2, n=40 |
|
| DBP, Week 4, n=37 |
|
| DBP, Week 6, n=36 |
|
| DBP, Week 8, n=36 |
|
| DBP, Week 12, n=36 |
|
| DBP, Week 16, n=36 |
|
| DBP, Week 20, n=36 |
|
| DBP, Week 24, n=36 |
|
| DBP, Week 28, n=34 |
|
| DBP, Week 32, n=34 |
|
| DBP, Week 36, n=34 |
|
| DBP, Week 40, n=33 |
|
| DBP, Week 44, n=31 |
|
| DBP, Week 48, n=31 |
|
| DBP, withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| SBP, Week 24, n=37 |
|
| DBP, FU Baseline, n=40 |
|
| DBP, FU Week 4, n=40 |
|
| DBP, FU Week 12, n=40 |
|
| DBP, FU Week 24, n=37 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=6 |
|
| Week 5, n=3 |
|
| Week 6, n=3 |
|
| Week 7, n=3 |
|
| Week 8, n=2 |
|
| Week 9, n=1 |
|
| Withdrawal, n=4 |
|
| FU Week 4, n=3 |
|
| FU Week 12, n=3 |
|
| FU Week 24, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=37 |
|
| Week 6, n=36 |
|
| Week 8, n=36 |
|
| Week 12, n=36 |
|
| Week 16, n=36 |
|
| Week 20, n=36 |
|
| Week 24, n=36 |
|
| Week 28, n=34 |
|
| Week 32, n=34 |
|
| Week 36, n=34 |
|
| Week 40, n=33 |
|
| Week 44, n=31 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, n=37 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=6 |
|
| Week 5, n=3 |
|
| Week 6, n=3 |
|
| Week 7, n=3 |
|
| Week 8, n=2 |
|
| Week 9, n=1 |
|
| Withdrawal, n=4 |
|
| FU Week 4, n=3 |
|
| FU Week 12, n=3 |
|
| FU Week 24, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=37 |
|
| Week 6, n=36 |
|
| Week 8, n=36 |
|
| Week 12, n=36 |
|
| Week 16, n=36 |
|
| Week 20, n=36 |
|
| Week 24, n=36 |
|
| Week 28, n=34 |
|
| Week 32, n=34 |
|
| Week 36, n=34 |
|
| Week 40, n=33 |
|
| Week 44, n=31 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, n=37 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=6 |
|
| Week 5, n=3 |
|
| Week 6, n=3 |
|
| Week 7, n=3 |
|
| Week 8, n=2 |
|
| Week 9, n=1 |
|
| Withdrawal, n=4 |
|
| FU Week 4, n=3 |
|
| FU Week 12, n=3 |
|
| FU Week 24, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=37 |
|
| Week 6, n=36 |
|
| Week 8, n=36 |
|
| Week 12, n=36 |
|
| Week 16, n=36 |
|
| Week 20, n=36 |
|
| Week 24, n=36 |
|
| Week 28, n=34 |
|
| Week 32, n=34 |
|
| Week 36, n=34 |
|
| Week 40, n=33 |
|
| Week 44, n=31 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, n=37 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=6 |
|
| Week 5, n=3 |
|
| Week 6, n=3 |
|
| Week 7, n=3 |
|
| Week 8, n=2 |
|
| Week 9, n=1 |
|
| Withdrawal, n=4 |
|
| FU, Week 4, n=3 |
|
| FU, Week 12, n=3 |
|
| FU, Week 24, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 4, n=37 |
|
| Week 6, n=36 |
|
| Week 8, n=36 |
|
| Week 12, n=36 |
|
| Week 16, n=36 |
|
| Week 20, n=36 |
|
| Week 24, n=36 |
|
| Week 28, n=34 |
|
| Week 32, n=34 |
|
| Week 36, n=34 |
|
| Week 40, n=33 |
|
| Week 44, n=31 |
|
| Week 48, n=31 |
|
| Withdrawal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, n=37 |
|
| Title | Measurements |
|---|---|
|
| Albumin: Increase to G3 |
|
| Albumin: Increase to G4 |
|
| ALP: Any Grade Increase |
|
| ALP: Increase to G1 |
|
| ALP: Increase to G2 |
|
| ALP: Increase to G3 |
|
| ALP: Increase to G4 |
|
| ALT: Any Grade Increase |
|
| ALT: Increase to G1 |
|
| ALT: Increase to G2 |
|
| ALT: Increase to G3 |
|
| ALT: Increase to G4 |
|
| AST:Any Grade Increase |
|
| AST:Increase to G1 |
|
| AST:Increase to G2 |
|
| AST:Increase to G3 |
|
| AST:Increase to G4 |
|
| Total Bilirubin:Any Grade Increase |
|
| Total Bilirubin:Increase to G1 |
|
| Total Bilirubin:Increase to G2 |
|
| Total Bilirubin:Increase to G3 |
|
| Total Bilirubin:Increase to G4 |
|
| Calcium:Any Grade Increase |
|
| Calcium:Increase to G1 |
|
| Calcium:Increase to G2 |
|
| Calcium:Increase to G3 |
|
| Calcium:Increase to G4 |
|
| Creatinine:Any Grade Increase |
|
| Creatinine:Increase to G1 |
|
| Creatinine:Increase to G2 |
|
| Creatinine:Increase to G3 |
|
| Creatinine:Increase to G4 |
|
| Potassium:Any Grade Increase |
|
| Potassium:Increase to G1 |
|
| Potassium:Increase to G2 |
|
| Potassium:Increase to G3 |
|
| Potassium:Increase to G4 |
|
| Sodium:Any Grade Increase |
|
| Sodium:Increase to G1 |
|
| Sodium:Increase to G2 |
|
| Sodium:Increase to G3 |
|
| Sodium:Increase to G4 |
|
| Uric Acid:Any Grade Increase |
|
| Uric acid:Increase to G1 |
|
| Uric acid:Increase to G2 |
|
| Uric acid:Increase to G3 |
|
| Uric acid:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Albumin:Increase to G3 |
|
| Albumin:Increase to G4 |
|
| ALP:Any Grade Increase |
|
| ALP:Increase to G1 |
|
| ALP:Increase to G2 |
|
| ALP:Increase to G3 |
|
| ALP:Increase to G4 |
|
| ALT:Any Grade Increase |
|
| ALT:Increase to G1 |
|
| ALT:Increase to G2 |
|
| ALT:Increase to G3 |
|
| ALT:Increase to G4 |
|
| AST:Any Grade Increase |
|
| AST:Increase to G1 |
|
| AST:Increase to G2 |
|
| AST:Increase to G3 |
|
| AST:Increase to G4 |
|
| Total Bilirubin:Any Grade Increase |
|
| Total Bilirubin:Increase to G1 |
|
| Total Bilirubin:Increase to G2 |
|
| Total Bilirubin:Increase to G3 |
|
| Total Bilirubin:Increase to G4 |
|
| Calcium:Any Grade Increase |
|
| Calcium:Increase to G1 |
|
| Calcium:Increase to G2 |
|
| Calcium:Increase to G3 |
|
| Calcium:Increase to G4 |
|
| Creatinine:Any Grade Increase |
|
| Creatinine:Increase to G1 |
|
| Creatinine:Increase to G2 |
|
| Creatinine:Increase to G3 |
|
| Creatinine:Increase to G4 |
|
| Potassium:Any Grade Increase |
|
| Potassium:Increase to G1 |
|
| Potassium:Increase to G2 |
|
| Potassium:Increase to G3 |
|
| Potassium:Increase to G4 |
|
| Sodium:Any Grade Increase |
|
| Sodium:Increase to G1 |
|
| Sodium:Increase to G2 |
|
| Sodium:Increase to G3 |
|
| Sodium:Increase to G4 |
|
| Uric acid:Any Grade Increase |
|
| Uric acid:Increase to G1 |
|
| Uric acid:Increase to G2 |
|
| Uric acid:Increase to G3 |
|
| Uric acid:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Albumin:Increase to G3 |
|
| Albumin:Increase to G4 |
|
| ALP:Any Grade Increase |
|
| ALP:Increase to G1 |
|
| ALP:Increase to G2 |
|
| ALP:Increase to G3 |
|
| ALP:Increase to G4 |
|
| ALT:Any Grade Increase |
|
| ALT:Increase to G1 |
|
| ALT:Increase to G2 |
|
| ALT:Increase to G3 |
|
| ALT:Increase to G4 |
|
| AST:Any Grade Increase |
|
| AST:Increase to G1 |
|
| AST:Increase to G2 |
|
| AST:Increase to G3 |
|
| AST:Increase to G4 |
|
| Total Bilirubin:Any Grade Increase |
|
| Total Bilirubin:Increase to G1 |
|
| Total Bilirubin:Increase to G2 |
|
| Total Bilirubin:Increase to G3 |
|
| Total Bilirubin:Increase to G4 |
|
| Calcium:Any Grade Increase |
|
| Calcium:Increase to G1 |
|
| Calcium:Increase to G2 |
|
| Calcium:Increase to G3 |
|
| Calcium:Increase to G4 |
|
| Calcium serum high: Any Grade Increase |
|
| Calcium, serum high: Increase to G1 |
|
| Calcium, serum high: Increase to G2 |
|
| Calcium, serum high: Increase to G3 |
|
| Calcium, serum high: Increase to G4 |
|
| Calcium serum low: Any Grade Increase |
|
| Calcium, serum low: Increase to G1 |
|
| Calcium, serum low: Increase to G2 |
|
| Calcium, serum low: Increase to G3 |
|
| Calcium, serum low: Increase to G4 |
|
| Creatinine: Any Grade Increase |
|
| Creatinine: Increase to G1 |
|
| Creatinine: Increase to G2 |
|
| Creatinine: Increase to G3 |
|
| Creatinine: Increase to G4 |
|
| Potassium:Any Grade Increase |
|
| Potassium:Increase to G1 |
|
| Potassium:Increase to G2 |
|
| Potassium:Increase to G3 |
|
| Potassium:Increase to G4 |
|
| Potassium, serum high:Any Grade Increase |
|
| Potassium, serum high:Increase to G1 |
|
| Potassium, serum high:Increase to G2 |
|
| Potassium, serum high:Increase to G3 |
|
| Potassium, serum high:Increase to G4 |
|
| Potassium, serum low:Any Grade Increase |
|
| Potassium, serum low:Increase to G1 |
|
| Potassium, serum low:Increase to G2 |
|
| Potassium, serum low:Increase to G3 |
|
| Potassium, serum low:Increase to G4 |
|
| Sodium:Any Grade Increase |
|
| Sodium:Increase to G1 |
|
| Sodium:Increase to G2 |
|
| Sodium:Increase to G3 |
|
| Sodium:Increase to G4 |
|
| Sodium, serum high:Any Grade Increase |
|
| Sodium, serum high:Increase to G1 |
|
| Sodium, serum high:Increase to G2 |
|
| Sodium, serum high:Increase to G3 |
|
| Sodium, serum high:Increase to G4 |
|
| Sodium, serum low:Any Grade Increase |
|
| Sodium, serum low:Increase to G1 |
|
| Sodium, serum low:Increase to G2 |
|
| Sodium, serum low:Increase to G3 |
|
| Sodium, serum low:Increase to G4 |
|
| Uric acid:Any Grade Increase |
|
| Uric acid:Increase to G1 |
|
| Uric acid:Increase to G2 |
|
| Uric acid:Increase to G3 |
|
| Uric acid:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Hemoglobin:Increase to G3 |
|
| Hemoglobin:Increase to G4 |
|
| Lymphocytes:Any Grade Increase |
|
| Lymphocytes:Increase to G1 |
|
| Lymphocytes:Increase to G2 |
|
| Lymphocytes:Increase to G3 |
|
| Lymphocytes:Increase to G4 |
|
| Total Neutrophils:Any Grade Increase |
|
| Total Neutrophils:Increase to G1 |
|
| Total Neutrophils:Increase to G2 |
|
| Total Neutrophils:Increase to G3 |
|
| Total Neutrophils:Increase to G4 |
|
| Platelet count:Any Grade Increase |
|
| Platelet count:Increase to G1 |
|
| Platelet count:Increase to G2 |
|
| Platelet count:Increase to G3 |
|
| Platelet count:Increase to G4 |
|
| White Blood Cell count:Any Grade Increase |
|
| White Blood Cell count:Increase to G1 |
|
| White Blood Cell count:Increase to G2 |
|
| White Blood Cell count:Increase to G3 |
|
| White Blood Cell count:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Hemoglobin:Increase to G3 |
|
| Hemoglobin:Increase to G4 |
|
| Lymphocytes:Any Grade Increase |
|
| Lymphocytes:Increase to G1 |
|
| Lymphocytes:Increase to G2 |
|
| Lymphocytes:Increase to G3 |
|
| Lymphocytes:Increase to G4 |
|
| Total Neutrophils:Any Grade Increase |
|
| Total Neutrophils:Increase to G1 |
|
| Total Neutrophils:Increase to G2 |
|
| Total Neutrophils:Increase to G3 |
|
| Total Neutrophils:Increase to G4 |
|
| Platelet count:Any Grade Increase |
|
| Platelet count:Increase to G1 |
|
| Platelet count:Increase to G2 |
|
| Platelet count:Increase to G3 |
|
| Platelet count:Increase to G4 |
|
| White Blood Cell count:Any Grade Increase |
|
| White Blood Cell count:Increase to G1 |
|
| White Blood Cell count:Increase to G2 |
|
| White Blood Cell count:Increase to G3 |
|
| White Blood Cell count:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Hemoglobin:Increase to G3 |
|
| Hemoglobin:Increase to G4 |
|
| Lymphocytes:Any Grade Increase |
|
| Lymphocytes:Increase to G1 |
|
| Lymphocytes:Increase to G2 |
|
| Lymphocytes:Increase to G3 |
|
| Lymphocytes:Increase to G4 |
|
| Total Neutrophils:Any Grade Increase |
|
| Total Neutrophils:Increase to G1 |
|
| Total Neutrophils:Increase to G2 |
|
| Total Neutrophils:Increase to G3 |
|
| Total Neutrophils:Increase to G4 |
|
| Platelet count:Any Grade Increase |
|
| Platelet count:Increase to G1 |
|
| Platelet count:Increase to G2 |
|
| Platelet count:Increase to G3 |
|
| Platelet count:Increase to G4 |
|
| White Blood Cell count:Any Grade Increase |
|
| White Blood Cell count:Increase to G1 |
|
| White Blood Cell count:Increase to G2 |
|
| White Blood Cell count:Increase to G3 |
|
| White Blood Cell count:Increase to G4 |
|
| Title | Measurements |
|---|---|
|
| Screening, UOB, 2+, n=45 |
|
| Screening, UOB, 3+, n=45 |
|
| Screening, UOB, (-), n=45 |
|
| Screening, UOB, Neg., n=45 |
|
| Screening, UOB, trace., n=45 |
|
| Screening, UG, (-), n=45 |
|
| Screening, UG, 0.5, n=45 |
|
| Screening, UG, Neg., n=45 |
|
| Screening, UK, (-), n=45 |
|
| Screening, UK, Neg., n=45 |
|
| Screening, pH, 5, n=45 |
|
| Screening, pH, 5.5, n=45 |
|
| Screening, pH, 6, n=45 |
|
| Screening, pH, 6.5, n=45 |
|
| Screening, pH, 7, n=45 |
|
| Screening, pH, 7.5, n=45 |
|
| Screening, UP, 1+., n=45 |
|
| Screening, UP, (-), n=45 |
|
| Screening, UP, Neg., n=45 |
|
| Screening, UP, trace, n=45 |
|
| Screening, UU, 1+, n=45 |
|
| Screening, UU, (-), n=45 |
|
| Screening, UU, 0.1, n=45 |
|
| Screening, UU, 1, n=45 |
|
| Screening, UU, 2, n=45 |
|
| Screening, UU, trace, n=45 |
|
| Screening, UU, normal, n=45 |
|
| Screening, USG, 1.005, n=45 |
|
| Screening, USG, 1.006, n=45 |
|
| Screening, USG, 1.007, n=45 |
|
| Screening, USG, 1.008, n=45 |
|
| Screening, USG, 1.009, n=45 |
|
| Screening, USG, 1.01, n=45 |
|
| Screening, USG, 1.011, n=45 |
|
| Screening, USG, 1.012, n=45 |
|
| Screening, USG, 1.013, n=45 |
|
| Screening, USG, 1.014, n=45 |
|
| Screening, USG, 1.015, n=45 |
|
| Screening, USG, 1.017, n=45 |
|
| Screening, USG, 1.018, n=45 |
|
| Screening, USG, 1.019, n=45 |
|
| Screening, USG, 1.02, n=45 |
|
| Screening, USG, 1.021, n=45 |
|
| Screening, USG, 1.022, n=45 |
|
| Screening, USG, 1.024, n=45 |
|
| Screening, USG, 1.025, n=45 |
|
| Screening, USG, 1.026, n=45 |
|
| Screening, USG, 1.03, n=45 |
|
| Baseline, UB, (-), n=45 |
|
| Baseline, UB, Neg., n=45 |
|
| Baseline, UOB, 1+, n=45 |
|
| Baseline, UOB, 2+, n=45 |
|
| Baseline, UOB, 3+, n=45 |
|
| Baseline, UOB, (-), n=45 |
|
| Baseline, UOB, Neg., n=45 |
|
| Baseline, UOB, trace., n=45 |
|
| Baseline, UG, 2+, n=45 |
|
| Baseline, UG, (-), n=45 |
|
| Baseline, UG, 0.1, n=45 |
|
| Baseline, UG, 0.5, n=45 |
|
| Baseline, UG, Neg., n=45 |
|
| Baseline, UK, (-), n=45 |
|
| Baseline, UK, Neg., n=45 |
|
| Baseline, pH, 5, n=45 |
|
| Baseline, pH, 5.5, n=45 |
|
| Baseline, pH, 6, n=45 |
|
| Baseline, pH, 6.5, n=45 |
|
| Baseline, pH, 7, n=45 |
|
| Baseline, pH, 7.5, n=45 |
|
| Baseline, pH, 8, n=45 |
|
| Baseline, UP, 1+., n=45 |
|
| Baseline, UP, (-), n=45 |
|
| Baseline, UP, Neg., n=45 |
|
| Baseline, UP, trace, n=45 |
|
| Baseline, UU, 1+, n=45 |
|
| Baseline, UU, (-), n=45 |
|
| Baseline, UU, 0.1, n=45 |
|
| Baseline, UU, 1, n=45 |
|
| Baseline, UU, 2, n=45 |
|
| Baseline, UU, trace, n=45 |
|
| Baseline, UU, normal, n=45 |
|
| Baseline, USG, 1.003, n=45 |
|
| Baseline, USG, 1.005, n=45 |
|
| Baseline, USG, 1.006, n=45 |
|
| Baseline, USG, 1.007, n=45 |
|
| Baseline, USG, 1.009, n=45 |
|
| Baseline, USG, 1.01, n=45 |
|
| Baseline, USG, 1.011, n=45 |
|
| Baseline, USG, 1.012, n=45 |
|
| Baseline, USG, 1.013, n=45 |
|
| Baseline, USG, 1.014, n=45 |
|
| Baseline, USG, 1.015, n=45 |
|
| Baseline, USG, 1.016, n=45 |
|
| Baseline, USG, 1.017, n=45 |
|
| Baseline, USG, 1.018, n=45 |
|
| Baseline, USG, 1.019, n=45 |
|
| Baseline, USG, 1.02, n=45 |
|
| Baseline, USG, 1.021, n=45 |
|
| Baseline, USG, 1.022, n=45 |
|
| Baseline, USG, 1.023, n=45 |
|
| Baseline, USG, 1.025, n=45 |
|
| Baseline, USG, 1.028, n=45 |
|
| Baseline, USG, 1.03, n=45 |
|
| Week 1, UB, Neg, n=1 |
|
| Week 1, UOB, Neg, n=1 |
|
| Week 1, UG, Neg, n=1 |
|
| Week 1, UK, Neg, n=1 |
|
| Week 1, pH, 7.5, n=1 |
|
| Week 1, UP, trace, n=1 |
|
| Week 1, USG, 1.021, n=1 |
|
| Week 1, UU, trace, n=1 |
|
| Week 2, UB, Neg, n=3 |
|
| Week 2, UOB, Neg, n=3 |
|
| Week 2, UG, 0.25, n=3 |
|
| Week 2, UG, Neg, n=3 |
|
| Week 2, UK, Neg, n=3 |
|
| Week 2, pH, 6, n=3 |
|
| Week 2, pH, 6.5, n=3 |
|
| Week 2, UP, Neg, n=3 |
|
| Week 2, USG, 1.016, Neg, n=3 |
|
| Week 2, USG, 1.019, n=3 |
|
| Week 2, USG, 1.02, n=3 |
|
| Week 2, UU, 0.1, n=3 |
|
| Week 2, UU, trace, n=3 |
|
| Week 2, UU, normal, n=3 |
|
| Week 3, UB, Neg, n=2 |
|
| Week 3, UOB, Neg, n=2 |
|
| Week 3, UG, >=1.0, n=2 |
|
| Week 3, UG, Neg, n=2 |
|
| Week 3, UK, Neg, n=2 |
|
| Week 3, pH, 6, n=2 |
|
| Week 3, pH, 6.5, n=2 |
|
| Week 3, UP, Neg, n=2 |
|
| Week 3, USG, 1.015, n=2 |
|
| Week 3, USG, 1.02, n=2 |
|
| Week 3, UU, 0.1, n=2 |
|
| Week 3, UU, 4, n=2 |
|
| Week 4, UB, Neg, n=5 |
|
| Week 4, UOB, Neg, n=5 |
|
| Week 4, UG, >=1.0, n=5 |
|
| Week 4, UG, Neg, n=5 |
|
| Week 4, UK, Neg, n=5 |
|
| Week 4, pH, 5.5, n=5 |
|
| Week 4, pH, 6, n=5 |
|
| Week 4, pH, 6.5, n=5 |
|
| Week 4, UP, Neg, n=5 |
|
| Week 4, USG, 1.015, n=5 |
|
| Week 4, USG, 1.02, n=5 |
|
| Week 4, USG, 1.025, n=5 |
|
| Week 4, USG, 1.026, n=5 |
|
| Week 4, UU, 1, n=5 |
|
| Week 4, UU, 2, n=5 |
|
| Week 4, UU, trace, n=5 |
|
| Week 7, UB, Neg, n=1 |
|
| Week 7, UOB, Neg, n=1 |
|
| Week 7, UG, 0.5, n=1 |
|
| Week 7, UK, Neg, n=1 |
|
| Week 7, pH, 7, n=1 |
|
| Week 7, UP, Neg, n=1 |
|
| Week 7, USG, 1.02, n=1 |
|
| Week 7, UU, 2, n=1 |
|
| Week 8, UB, Neg, n=2 |
|
| Week 8, UOB, Neg, n=2 |
|
| Week 8, UOB, trace, n=2 |
|
| Week 8, UG, 0.1 n=2 |
|
| Week 8, UG, Neg, n=2 |
|
| Week 8, UK, Neg, n=2 |
|
| Week 8, pH, 6, n=2 |
|
| Week 8, UP, Neg, n=2 |
|
| Week 8, USG, 1.023, n=2 |
|
| Week 8, USG, 1.025, n=2 |
|
| Week 8, UU, 0.1, n=2 |
|
| Week 8, UU, trace, n=2 |
|
| Withdrawal, UB, Neg, n=4 |
|
| Withdrawal, UOB, Neg, n=4 |
|
| Withdrawal, UG, 0.5, n=4 |
|
| Withdrawal, UG, Neg, n=4 |
|
| Withdrawal, UK, Neg, n=4 |
|
| Withdrawal, pH, 6, n=4 |
|
| Withdrawal, pH, 6.5, n=4 |
|
| Withdrawal, pH, 8, n=4 |
|
| Withdrawal, UP, Neg, n=4 |
|
| Withdrawal, USG, 1.008, n=4 |
|
| Withdrawal, USG, 1.01, n=4 |
|
| Withdrawal, USG, 1.018, n=4 |
|
| Withdrawal, USG, 1.025, n=4 |
|
| Withdrawal, UU, 1+, n=4 |
|
| Withdrawal, UU, 0.1, n=4 |
|
| Withdrawal, UU, 1, n=4 |
|
| FU, Week 24, UB, Neg, n=3 |
|
| FU Week 24, UOB, 1+, n=3 |
|
| FU Week 24, UOB, Neg, n=3 |
|
| FU Week 24, UG, Neg, n=3 |
|
| FU Week 24, UK, Neg, n=3 |
|
| FU Week 24, pH, 5.5, n=3 |
|
| FU Week 24, pH, 6, n=3 |
|
| FU Week 24, pH, 7, n=3 |
|
| FU Week 24, UP, Neg, n=3 |
|
| FU Week 24, USG, 1.004, n=3 |
|
| FU Week 24, USG, 1.01, n=3 |
|
| FU Week 24, USG, 1.02, n=3 |
|
| FU Week 24, UU, 0.1, n=3 |
|
| FU Week 24, UU, 1, n=3 |
|
| FU Week 24, UU, trace, n=3 |
|
| Title | Measurements |
|---|---|
|
| Antiviral Baseline, UOB, (-), n=41 |
|
| Antiviral Baseline, UOB, Neg., n=41 |
|
| Antiviral Baseline, UOB, trace., n=41 |
|
| Antiviral Baseline, UG, 1+, n=41 |
|
| Antiviral Baseline, UG, 2+, n=41 |
|
| Antiviral Baseline, UG, (-), n=41 |
|
| Antiviral Baseline, UG, 0.25, n=41 |
|
| Antiviral Baseline, UG, 0.5, n=41 |
|
| Antiviral Baseline, UG, >=1.0, n=41 |
|
| Antiviral Baseline, UG, Neg., n=41 |
|
| Antiviral Baseline, UK, (-), n=41 |
|
| Antiviral Baseline, UK, Neg., n=41 |
|
| Antiviral Baseline, UK, trace, n=41 |
|
| Antiviral Baseline, pH, 5, n=41 |
|
| Antiviral Baseline, pH, 5.5, n=41 |
|
| Antiviral Baseline, pH, 6, n=41 |
|
| Antiviral Baseline, pH, 6.5, n=41 |
|
| Antiviral Baseline, pH, 7, n=41 |
|
| Antiviral Baseline, pH, 7.5, n=41 |
|
| Antiviral Baseline, pH, 8.5, n=41 |
|
| Antiviral Baseline, UP, (-), n=41 |
|
| Antiviral Baseline, UP, Neg, n=41 |
|
| Antiviral Baseline, UP, trace, n=41 |
|
| Antiviral Baseline, USG, 1.005, n=41 |
|
| Antiviral Baseline, USG, 1.006, n=41 |
|
| Antiviral Baseline, USG, 1.01, n=41 |
|
| Antiviral Baseline, USG, 1.011, n=41 |
|
| Antiviral Baseline, USG, 1.012, n=41 |
|
| Antiviral Baseline, USG, 1.013, n=41 |
|
| Antiviral Baseline, USG, 1.014, n=41 |
|
| Antiviral Baseline, USG, 1.015, n=41 |
|
| Antiviral Baseline, USG, 1.016, n=41 |
|
| Antiviral Baseline, USG, 1.017, n=41 |
|
| Antiviral Baseline, USG, 1.018, n=41 |
|
| Antiviral Baseline, USG, 1.019, n=41 |
|
| Antiviral Baseline, USG, 1.02, n=41 |
|
| Antiviral Baseline, USG, 1.021, n=41 |
|
| Antiviral Baseline, USG, 1.022, n=41 |
|
| Antiviral Baseline, USG, 1.023, n=41 |
|
| Antiviral Baseline, USG, 1.024, n=41 |
|
| Antiviral Baseline, USG, 1.025, n=41 |
|
| Antiviral Baseline, USG, 1.026, n=41 |
|
| Antiviral Baseline, USG, 1.027, n=41 |
|
| Antiviral Baseline, UU, 1+, n=41 |
|
| Antiviral Baseline, UU, 0.1, n=41 |
|
| Antiviral Baseline, UU, 1, n=41 |
|
| Antiviral Baseline, UU, 2, n=41 |
|
| Antiviral Baseline, UU, 4, n=41 |
|
| Antiviral Baseline, UU, Neg, n=41 |
|
| Antiviral Baseline, UU, trace, n=41 |
|
| Antiviral Baseline, UU, normal, n=41 |
|
| Week 4, UB, (-), n=37 |
|
| Week 4, UB, Neg, n=37 |
|
| Week 4, UOB, 2+, n=37 |
|
| Week 4, UOB, (-), n=37 |
|
| Week 4, UOB, Neg, n=37 |
|
| Week 4, UG, (-), n=37 |
|
| Week 4, UG, 0.1, n=37 |
|
| Week 4, UG, Neg, n=37 |
|
| Week 4, UK, (-), n=37 |
|
| Week 4, UK, Neg, n=37 |
|
| Week 4, pH, 5, n=37 |
|
| Week 4, pH, 5.5, n=37 |
|
| Week 4, pH, 6, n=37 |
|
| Week 4, pH, 6.5, n=37 |
|
| Week 4, pH, 7, n=37 |
|
| Week 4, pH, 7.5, n=37 |
|
| Week 4, pH, 8, n=37 |
|
| Week 4, UP, (-), n=37 |
|
| Week 4, UP, Neg, n=37 |
|
| Week 4, UP, trace, n=37 |
|
| Week 4, USG, 1.004, n=37 |
|
| Week 4, USG, 1.005, n=37 |
|
| Week 4, USG, 1.006, n=37 |
|
| Week 4, USG, 1.008, n=37 |
|
| Week 4, USG, 1.01, n=37 |
|
| Week 4, USG, 1.011, n=37 |
|
| Week 4, USG, 1.012, n=37 |
|
| Week 4, USG, 1.013, n=37 |
|
| Week 4, USG, 1.014, n=37 |
|
| Week 4, USG, 1.015, n=37 |
|
| Week 4, USG, 1.016, n=37 |
|
| Week 4, USG, 1.017, n=37 |
|
| Week 4, USG, 1.019, n=37 |
|
| Week 4, USG, 1.02, n=37 |
|
| Week 4, USG, 1.021, n=37 |
|
| Week 4, USG, 1.022, n=37 |
|
| Week 4, USG, 1.025, n=37 |
|
| Week 4, UU, 1+, n=37 |
|
| Week 4, UU, 0.1, n=37 |
|
| Week 4, UU, 1, n=37 |
|
| Week 4, UU, 2, n=37 |
|
| Week 4, UU, 4, n=37 |
|
| Week 4, UU, 8, n=37 |
|
| Week 4, UU, Neg, n=37 |
|
| Week 4, UU, trace, n=37 |
|
| Week 4, UU, normal, n=37 |
|
| Week 8, UB, (-), n=36 |
|
| Week 8, UB, 2, n=36 |
|
| Week 8, UB, Neg, n=36 |
|
| Week 8, UOB, 1+, n=36 |
|
| Week 8, UOB, 2+, n=36 |
|
| Week 8, UOB, (-), n=36 |
|
| Week 8, UOB, Neg, n=36 |
|
| Week 8, UG, 1+, n=36 |
|
| Week 8, UG, (-), n=36 |
|
| Week 8, UG, >=1.0, n=36 |
|
| Week 8, UG, Neg, n=36 |
|
| Week 8, UK, (-), n=36 |
|
| Week 8, UK, Neg, n=36 |
|
| Week 8, UK, trace, n=36 |
|
| Week 8, pH, 5, n=36 |
|
| Week 8, pH, 5.5, n=36 |
|
| Week 8, pH, 6, n=36 |
|
| Week 8, pH, 6.5, n=36 |
|
| Week 8, pH, 7, n=36 |
|
| Week 8, pH, 7.5, n=36 |
|
| Week 8, pH, 8, n=36 |
|
| Week 8, UP, 1+, n=36 |
|
| Week 8, UP, (-), n=36 |
|
| Week 8, UP, Neg, n=36 |
|
| Week 8, UP, trace, n=36 |
|
| Week 8, USG, 1.001, n=36 |
|
| Week 8, USG, 1.003, n=36 |
|
| Week 8, USG, 1.004, n=36 |
|
| Week 8, USG, 1.005, n=36 |
|
| Week 8, USG, 1.008, n=36 |
|
| Week 8, USG, 1.01, n=36 |
|
| Week 8, USG, 1.012, n=36 |
|
| Week 8, USG, 1.013, n=36 |
|
| Week 8, USG, 1.014, n=36 |
|
| Week 8, USG, 1.015, n=36 |
|
| Week 8, USG, 1.016, n=36 |
|
| Week 8, USG, 1.018, n=36 |
|
| Week 8, USG, 1.019, n=36 |
|
| Week 8, USG, 1.02, n=36 |
|
| Week 8, USG, 1.023, n=36 |
|
| Week 8, USG, 1.025, n=36 |
|
| Week 8, USG, <=1.005, n=36 |
|
| Week 8, USG, >=1.030, n=36 |
|
| Week 8, UU, 1+, n=36 |
|
| Week 8, UU, (-), n=36 |
|
| Week 8, UU, 0.1, n=36 |
|
| Week 8, UU, 1, n=36 |
|
| Week 8, UU, 2, n=36 |
|
| Week 8, UU, 4, n=36 |
|
| Week 8, UU, Neg, n=36 |
|
| Week 8, UU, trace, n=36 |
|
| Week 8, UU, normal, n=36 |
|
| Week 12, UB, (-), n=36 |
|
| Week 12, UB, Neg, n=36 |
|
| Week 12, UOB, (-), n=36 |
|
| Week 12, UOB, Neg, n=36 |
|
| Week 12, UG, (-), n=36 |
|
| Week 12, UG, 0.25, n=36 |
|
| Week 12, UG, Neg, n=36 |
|
| Week 12, UK, (-), n=36 |
|
| Week 12, UK, 0, n=36 |
|
| Week 12, UK, Neg, n=36 |
|
| Week 12, pH, 5, n=36 |
|
| Week 12, pH, 5.5, n=36 |
|
| Week 12, pH, 6, n=36 |
|
| Week 12, pH, 6.5, n=36 |
|
| Week 12, pH, 7, n=36 |
|
| Week 12, pH, 7.5, n=36 |
|
| Week 12, UP, 1+, n=36 |
|
| Week 12, UP, (-), n=36 |
|
| Week 12, UP, Neg, n=36 |
|
| Week 12, UP, trace, n=36 |
|
| Week 12, USG, 1.005, n=36 |
|
| Week 12, USG, 1.006, n=36 |
|
| Week 12, USG, 1.007, n=36 |
|
| Week 12, USG, 1.008, n=36 |
|
| Week 12, USG, 1.009, n=36 |
|
| Week 12, USG, 1.01, n=36 |
|
| Week 12, USG, 1.012, n=36 |
|
| Week 12, USG, 1.014, n=36 |
|
| Week 12, USG, 1.015, n=36 |
|
| Week 12, USG, 1.016, n=36 |
|
| Week 12, USG, 1.017, n=36 |
|
| Week 12, USG, 1.018, n=36 |
|
| Week 12, USG, 1.019, n=36 |
|
| Week 12, USG, 1.02, n=36 |
|
| Week 12, USG, 1.021, n=36 |
|
| Week 12, USG, 1.022, n=36 |
|
| Week 12, USG, 1.026, n=36 |
|
| Week 12, UU, 1+, n=36 |
|
| Week 12, UU, 0.1, n=36 |
|
| Week 12, UU, 1, n=36 |
|
| Week 12, UU, 2, n=36 |
|
| Week 12, UU, 4, n=36 |
|
| Week 12, UU, Neg, n=36 |
|
| Week 12, UU, trace, n=36 |
|
| Week 12, UU, normal, n=36 |
|
| Week 16, UB, (-), n=36 |
|
| Week 16, UB, Neg, n=36 |
|
| Week 16, UOB, 1+, n=36 |
|
| Week 16, UOB, 2+, n=36 |
|
| Week 16, UOB, 3+, n=36 |
|
| Week 16, UOB, (-), n=36 |
|
| Week 16, UOB, Neg, n=36 |
|
| Week 16, UG, (-), n=36 |
|
| Week 16, UG, 0.25, n=36 |
|
| Week 16, UG, Neg, n=36 |
|
| Week 16, UK, (-), n=36 |
|
| Week 16, UK, Neg, n=36 |
|
| Week 16, UK, trace, n=36 |
|
| Week 16, pH, 5, n=36 |
|
| Week 16, pH, 5.5, n=36 |
|
| Week 16, pH, 6, n=36 |
|
| Week 16, pH, 6.5, n=36 |
|
| Week 16, pH, 7, n=36 |
|
| Week 16, pH, 7.5, n=36 |
|
| Week 16, UP, 1+, n=36 |
|
| Week 16, UP, (-), n=36 |
|
| Week 16, UP, Neg, n=36 |
|
| Week 16, UP, trace, n=36 |
|
| Week 16, USG, 1.005, n=36 |
|
| Week 16, USG, 1.006, n=36 |
|
| Week 16, USG, 1.007, n=36 |
|
| Week 16, USG, 1.008, n=36 |
|
| Week 16, USG, 1.009, n=36 |
|
| Week 16, USG, 1.01, n=36 |
|
| Week 16, USG, 1.014, n=36 |
|
| Week 16, USG, 1.015, n=36 |
|
| Week 16, USG, 1.016, n=36 |
|
| Week 16, USG, 1.017, n=36 |
|
| Week 16, USG, 1.018, n=36 |
|
| Week 16, USG, 1.019, n=36 |
|
| Week 16, USG, 1.02, n=36 |
|
| Week 16, USG, 1.021, n=36 |
|
| Week 16, USG, 1.022, n=36 |
|
| Week 16, USG, 1.023, n=36 |
|
| Week 16, USG, 1.025, n=36 |
|
| Week 16, USG, 1.027, n=36 |
|
| Week 16, UU, 1+, n=36 |
|
| Week 16, UU, 2+, n=36 |
|
| Week 16, UU, 0.1, n=36 |
|
| Week 16, UU, 1, n=36 |
|
| Week 16, UU, 4, n=36 |
|
| Week 16, UU, Neg, n=36 |
|
| Week 16, UU, trace, n=36 |
|
| Week 16, UU, normal, n=36 |
|
| Week 20, UB, (-), n=36 |
|
| Week 20, UB, Neg, n=36 |
|
| Week 20, UOB, 1+, n=36 |
|
| Week 20, UOB, (-), n=36 |
|
| Week 20, UOB, Neg, n=36 |
|
| Week 20, UG, (-), n=36 |
|
| Week 20, UG, Neg, n=36 |
|
| Week 20, UG, trace, n=36 |
|
| Week 20, UK, (-), n=36 |
|
| Week 20, UK, Neg, n=36 |
|
| Week 20, pH, 5, n=36 |
|
| Week 20, pH, 5.5, n=36 |
|
| Week 20, pH, 6, n=36 |
|
| Week 20, pH, 6.5, n=36 |
|
| Week 20, pH, 7, n=36 |
|
| Week 20, pH, 7.5, n=36 |
|
| Week 20, UP, 1+, n=36 |
|
| Week 20, UP, (-), n=36 |
|
| Week 20, UP, Neg, n=36 |
|
| Week 20, UP, trace, n=36 |
|
| Week 20, USG, 1.004, n=36 |
|
| Week 20, USG, 1.005, n=36 |
|
| Week 20, USG, 1.006, n=36 |
|
| Week 20, USG, 1.007, n=36 |
|
| Week 20, USG, 1.009, n=36 |
|
| Week 20, USG, 1.01, n=36 |
|
| Week 20, USG, 1.013, n=36 |
|
| Week 20, USG, 1.014, n=36 |
|
| Week 20, USG, 1.015, n=36 |
|
| Week 20, USG, 1.016, n=36 |
|
| Week 20, USG, 1.017, n=36 |
|
| Week 20, USG, 1.018, n=36 |
|
| Week 20, USG, 1.019, n=36 |
|
| Week 20, USG, 1.02, n=36 |
|
| Week 20, USG, 1.021, n=36 |
|
| Week 20, USG, 1.025, n=36 |
|
| Week 20, USG, 1.029, n=36 |
|
| Week 20, USG, <=1.005, n=36 |
|
| Week 20, UU, 1+, n=36 |
|
| Week 20, UU, 2+, n=36 |
|
| Week 20, UU, 0.1, n=36 |
|
| Week 20, UU, 1, n=36 |
|
| Week 20, UU, 4, n=36 |
|
| Week 20, UU, 8, n=36 |
|
| Week 20, UU, Neg, n=36 |
|
| Week 20, UU, trace, n=36 |
|
| Week 20, UU, normal, n=36 |
|
| Week 24, UB, (-), n=36 |
|
| Week 24, UB, Neg, n=36 |
|
| Week 24, UOB, 1+, n=36 |
|
| Week 24, UOB, 3+, n=36 |
|
| Week 24, UOB, (-), n=36 |
|
| Week 24, UOB, Neg, n=36 |
|
| Week 24, UOB, trace, n=36 |
|
| Week 24, UG, (-), n=36 |
|
| Week 24, UG, 0.1, n=36 |
|
| Week 24, UG, Neg, n=36 |
|
| Week 24, UK, (-), n=36 |
|
| Week 24, UK, Neg, n=36 |
|
| Week 24, UK, trace, n=36 |
|
| Week 24, pH, 5, n=36 |
|
| Week 24, pH, 5.5, n=36 |
|
| Week 24, pH, 6, n=36 |
|
| Week 24, pH, 6.5, n=36 |
|
| Week 24, pH, 7, n=36 |
|
| Week 24, pH, 7.5, n=36 |
|
| Week 24, pH, 8.5, n=36 |
|
| Week 24, UP, (-), n=36 |
|
| Week 24, UP, Neg, n=36 |
|
| Week 24, UP, trace, n=36 |
|
| Week 24, USG, 1.008, n=36 |
|
| Week 24, USG, 1.009, n=36 |
|
| Week 24, USG, 1.01, n=36 |
|
| Week 24, USG, 1.011, n=36 |
|
| Week 24, USG, 1.012, n=36 |
|
| Week 24, USG, 1.013, n=36 |
|
| Week 24, USG, 1.014, n=36 |
|
| Week 24, USG, 1.015, n=36 |
|
| Week 24, USG, 1.016, n=36 |
|
| Week 24, USG, 1.017, n=36 |
|
| Week 24, USG, 1.018, n=36 |
|
| Week 24, USG, 1.019, n=36 |
|
| Week 24, USG, 1.021, n=36 |
|
| Week 24, USG, 1.022, n=36 |
|
| Week 24, USG, 1.023, n=36 |
|
| Week 24, USG, 1.025, n=36 |
|
| Week 24, USG, 1.03, n=36 |
|
| Week 24, USG, <=1.005, n=36 |
|
| Week 24, UU, 1+, n=36 |
|
| Week 24, UU, 3+, n=36 |
|
| Week 24, UU, 0.1, n=36 |
|
| Week 24, UU, 1, n=36 |
|
| Week 24, UU, 2, n=36 |
|
| Week 24, UU, 4, n=36 |
|
| Week 24, UU, Neg, n=36 |
|
| Week 24, UU, trace, n=36 |
|
| Week 24, UU, normal, n=36 |
|
| Week 28, UB, 1+, n=34 |
|
| Week 28, UB, (-), n=34 |
|
| Week 28, UB, Neg, n=34 |
|
| Week 28, UOB, 1+, n=34 |
|
| Week 28, UOB, (-), n=34 |
|
| Week 28, UOB, Neg, n=34 |
|
| Week 28, UOB, trace, n=34 |
|
| Week 28, UG, (-), n=34 |
|
| Week 28, UG, 0.5, n=34 |
|
| Week 28, UG, Neg, n=34 |
|
| Week 28, UK, (-), n=34 |
|
| Week 28, UK, Neg, n=34 |
|
| Week 28, UK, trace, n=34 |
|
| Week 28, pH, 5.5, n=34 |
|
| Week 28, pH, 6, n=34 |
|
| Week 28, pH, 6.5, n=34 |
|
| Week 28, pH, 7, n=34 |
|
| Week 28, pH, 7.5, n=34 |
|
| Week 28, pH, 8, n=34 |
|
| Week 28, UP, 1+, n=34 |
|
| Week 28, UP, Neg, n=34 |
|
| Week 28, UP, trace, n=34 |
|
| Week 28, USG, 1.005, n=34 |
|
| Week 28, USG, 1.007, n=34 |
|
| Week 28, USG, 1.008, n=34 |
|
| Week 28, USG, 1.009, n=34 |
|
| Week 28, USG, 1.011, n=34 |
|
| Week 28, USG, 1.012, n=34 |
|
| Week 28, USG, 1.013, n=34 |
|
| Week 28, USG, 1.015, n=34 |
|
| Week 28, USG, 1.016, n=34 |
|
| Week 28, USG, 1.017, n=34 |
|
| Week 28, USG, 1.018, n=34 |
|
| Week 28, USG, 1.019, n=34 |
|
| Week 28, USG, 1.02, n=34 |
|
| Week 28, USG, 1.022, n=34 |
|
| Week 28, USG, 1.023, n=34 |
|
| Week 28, USG, 1.024, n=34 |
|
| Week 28, USG, 1.025, n=34 |
|
| Week 28, USG, 1.027, n=34 |
|
| Week 28, USG, <=1.005, n=34 |
|
| Week 28, UU, 1+, n=34 |
|
| Week 28, UU, 0.1, n=34 |
|
| Week 28, UU, 1, n=34 |
|
| Week 28, UU, 2, n=34 |
|
| Week 28, UU, 4, n=34 |
|
| Week 28, UU, Neg, n=34 |
|
| Week 28, UU, trace, n=34 |
|
| Week 28, UU, normal, n=34 |
|
| Week 32, UB, (-), n=34 |
|
| Week 32, UB, Neg, n=34 |
|
| Week 32, UOB, 1+, n=34 |
|
| Week 32, UOB, (-), n=34 |
|
| Week 32, UOB, Neg, n=34 |
|
| Week 32, UG, (-), n=34 |
|
| Week 32, UG, Neg, n=34 |
|
| Week 32, UK, (-), n=34 |
|
| Week 32, UK, Neg, n=34 |
|
| Week 32, UK, trace, n=34 |
|
| Week 32, pH, 5, n=34 |
|
| Week 32, pH, 5.5, n=34 |
|
| Week 32, pH, 6, n=34 |
|
| Week 32, pH, 6.5, n=34 |
|
| Week 32, pH, 7, n=34 |
|
| Week 32, pH, 7.5, n=34 |
|
| Week 32, UP, (-), n=34 |
|
| Week 32, UP, Neg, n=34 |
|
| Week 32, UP, trace, n=34 |
|
| Week 32, USG, 1.005, n=34 |
|
| Week 32, USG, 1.006, n=34 |
|
| Week 32, USG, 1.007, n=34 |
|
| Week 32, USG, 1.01, n=34 |
|
| Week 32, USG, 1.011, n=34 |
|
| Week 32, USG, 1.012, n=34 |
|
| Week 32, USG, 1.014, n=34 |
|
| Week 32, USG, 1.015, n=34 |
|
| Week 32, USG, 1.016, n=34 |
|
| Week 32, USG, 1.018, n=34 |
|
| Week 32, USG, 1.019, n=34 |
|
| Week 32, USG, 1.02, n=34 |
|
| Week 32, USG, 1.021, n=34 |
|
| Week 32, USG, 1.022, n=34 |
|
| Week 32, USG, 1.024, n=34 |
|
| Week 32, UU, 1+, n=34 |
|
| Week 32, UU, 0.1, n=34 |
|
| Week 32, UU, 1, n=34 |
|
| Week 32, UU, 3, n=34 |
|
| Week 32, UU, 4, n=34 |
|
| Week 32, UU, 8, n=34 |
|
| Week 32, UU, Neg, n=34 |
|
| Week 32, UU, trace, n=34 |
|
| Week 32, UU, normal, n=34 |
|
| Week 36, UB, 1+, n=34 |
|
| Week 36, UB, (-), n=34 |
|
| Week 36, UB, Neg, n=34 |
|
| Week 36, UOB, 2+, n=34 |
|
| Week 36, UOB, (-), n=34 |
|
| Week 36, UOB, Neg, n=34 |
|
| Week 36, UG, (-), n=34 |
|
| Week 36, UG, Neg, n=34 |
|
| Week 36, UK, 1+, n=34 |
|
| Week 36, UK, (-), n=34 |
|
| Week 36, UK, Neg, n=34 |
|
| Week 36, pH, 5, n=34 |
|
| Week 36, pH, 5.5, n=34 |
|
| Week 36, pH, 6, n=34 |
|
| Week 36, pH, 6.5, n=34 |
|
| Week 36, pH, 7, n=34 |
|
| Week 36, pH, 7.5, n=34 |
|
| Week 36, UP, 1+, n=34 |
|
| Week 36, UP, (-), n=34 |
|
| Week 36, UP, Neg, n=34 |
|
| Week 36, UP, trace, n=34 |
|
| Week 36, USG, 1.005, n=34 |
|
| Week 36, USG, 1.007, n=34 |
|
| Week 36, USG, 1.008, n=34 |
|
| Week 36, USG, 1.009, n=34 |
|
| Week 36, USG, 1.01, n=34 |
|
| Week 36, USG, 1.011, n=34 |
|
| Week 36, USG, 1.012, n=34 |
|
| Week 36, USG, 1.013, n=34 |
|
| Week 36, USG, 1.015, n=34 |
|
| Week 36, USG, 1.016, n=34 |
|
| Week 36, USG, 1.018, n=34 |
|
| Week 36, USG, 1.02, n=34 |
|
| Week 36, USG, 1.021, n=34 |
|
| Week 36, USG, 1.023, n=34 |
|
| Week 36, USG, 1.024, n=34 |
|
| Week 36, USG, 1.03, n=34 |
|
| Week 36, USG, <=1.005, n=34 |
|
| Week 36, UU, 1+, n=34 |
|
| Week 36, UU, 0.1, n=34 |
|
| Week 36, UU, 1, n=34 |
|
| Week 36, UU, 2, n=34 |
|
| Week 36, UU, 3, n=34 |
|
| Week 36, UU, 4, n=34 |
|
| Week 36, UU, Neg, n=34 |
|
| Week 36, UU, trace, n=34 |
|
| Week 36, UU, normal, n=34 |
|
| Week 40, UB, (-), n=33 |
|
| Week 40, UB, Neg, n=33 |
|
| Week 40, UOB, 2+, n=33 |
|
| Week 40, UOB, 3+, n=33 |
|
| Week 40, UOB, (-), n=33 |
|
| Week 40, UOB, Neg, n=33 |
|
| Week 40, UG, (-), n=33 |
|
| Week 40, UG, Neg, n=33 |
|
| Week 40, UK, (-), n=33 |
|
| Week 40, UK, Neg, n=33 |
|
| Week 40, UK, trace, n=33 |
|
| Week 40, pH, 5.5, n=33 |
|
| Week 40, pH, 6, n=33 |
|
| Week 40, pH, 6.5, n=33 |
|
| Week 40, pH, 7, n=33 |
|
| Week 40, pH, 7.5, n=33 |
|
| Week 40, UP, (-), n=33 |
|
| Week 40, UP, Neg, n=33 |
|
| Week 40, UP, trace, n=33 |
|
| Week 40, USG, 1.003, n=33 |
|
| Week 40, USG, 1.004, n=33 |
|
| Week 40, USG, 1.005, n=33 |
|
| Week 40, USG, 1.006, n=33 |
|
| Week 40, USG, 1.007, n=33 |
|
| Week 40, USG, 1.01, n=33 |
|
| Week 40, USG, 1.011, n=33 |
|
| Week 40, USG, 1.012, n=33 |
|
| Week 40, USG, 1.013, n=33 |
|
| Week 40, USG, 1.014, n=33 |
|
| Week 40, USG, 1.015, n=33 |
|
| Week 40, USG, 1.016, n=33 |
|
| Week 40, USG, 1.018, n=33 |
|
| Week 40, USG, 1.019, n=33 |
|
| Week 40, USG, 1.02, n=33 |
|
| Week 40, USG, 1.022, n=33 |
|
| Week 40, USG, 1.023, n=33 |
|
| Week 40, USG, 1.024, n=33 |
|
| Week 40, USG, 1.025, n=33 |
|
| Week 40, UU, 1+, n=33 |
|
| Week 40, UU, 0.1, n=33 |
|
| Week 40, UU, 1, n=33 |
|
| Week 40, UU, 2, n=33 |
|
| Week 40, UU, 3, n=33 |
|
| Week 40, UU, 4, n=33 |
|
| Week 40, UU, Neg, n=33 |
|
| Week 40, UU, trace, n=33 |
|
| Week 40, UU, normal, n=33 |
|
| Week 44, UB, (-), n=31 |
|
| Week 44, UB, Neg, n=31 |
|
| Week 44, UOB, 2+, n=31 |
|
| Week 44, UOB, (-), n=31 |
|
| Week 44, UOB, Neg, n=31 |
|
| Week 44, UG, (-), n=31 |
|
| Week 44, UG, 0.1, n=31 |
|
| Week 44, UG, Neg, n=31 |
|
| Week 44, UK, (-), n=31 |
|
| Week 44, UK, Neg, n=31 |
|
| Week 44, UK, trace, n=31 |
|
| Week 44, pH, 5.5, n=31 |
|
| Week 44, pH, 6, n=31 |
|
| Week 44, pH, 6.5, n=31 |
|
| Week 44, pH, 7, n=31 |
|
| Week 44, pH, 7.5, n=31 |
|
| Week 44, UP, (-), n=31 |
|
| Week 44, UP, Neg, n=31 |
|
| Week 44, UP, trace, n=31 |
|
| Week 44, USG, 1.005, n=31 |
|
| Week 44, USG, 1.007, n=31 |
|
| Week 44, USG, 1.008, n=31 |
|
| Week 44, USG, 1.01, n=31 |
|
| Week 44, USG, 1.011, n=31 |
|
| Week 44, USG, 1.012, n=31 |
|
| Week 44, USG, 1.015, n=31 |
|
| Week 44, USG, 1.016, n=31 |
|
| Week 44, USG, 1.017, n=31 |
|
| Week 44, USG, 1.018, n=31 |
|
| Week 44, USG, 1.019, n=31 |
|
| Week 44, USG, 1.02, n=31 |
|
| Week 44, USG, 1.021, n=31 |
|
| Week 44, USG, 1.022, n=31 |
|
| Week 44, USG, 1.024, n=31 |
|
| Week 44, USG, 1.025, n=31 |
|
| Week 44, USG, 1.027, n=31 |
|
| Week 44, USG, 1.03, n=31 |
|
| Week 44, UU, 1+, n=31 |
|
| Week 44, UU, 2+, n=31 |
|
| Week 44, UU, 0.1, n=31 |
|
| Week 44, UU, 1, n=31 |
|
| Week 44, UU, 2, n=31 |
|
| Week 44, UU, 4, n=31 |
|
| Week 44, UU, Neg, n=31 |
|
| Week 44, UU, trace, n=31 |
|
| Week 44, UU, normal, n=31 |
|
| Week 48, UB, (-), n=31 |
|
| Week 48, UB, Neg, n=31 |
|
| Week 48, UOB, 3+, n=31 |
|
| Week 48, UOB, (-), n=31 |
|
| Week 48, UOB, Neg, n=31 |
|
| Week 48, UG, (-), n=31 |
|
| Week 48, UG, Neg, n=31 |
|
| Week 48, UK, (-), n=31 |
|
| Week 48, UK, Neg, n=31 |
|
| Week 48, pH, 5.5, n=31 |
|
| Week 48, pH, 6, n=31 |
|
| Week 48, pH, 6.5, n=31 |
|
| Week 48, pH, 7, n=31 |
|
| Week 48, pH, 8, n=31 |
|
| Week 48, UP, (-), n=31 |
|
| Week 48, UP, 10, n=31 |
|
| Week 48, UP, Neg, n=31 |
|
| Week 48, UP, trace, n=31 |
|
| Week 48, USG, 1.005, n=31 |
|
| Week 48, USG, 1.007, n=31 |
|
| Week 48, USG, 1.009, n=31 |
|
| Week 48, USG, 1.01, n=31 |
|
| Week 48, USG, 1.011, n=31 |
|
| Week 48, USG, 1.012, n=31 |
|
| Week 48, USG, 1.013, n=31 |
|
| Week 48, USG, 1.014, n=31 |
|
| Week 48, USG, 1.015, n=31 |
|
| Week 48, USG, 1.016, n=31 |
|
| Week 48, USG, 1.017, n=31 |
|
| Week 48, USG, 1.018, n=31 |
|
| Week 48, USG, 1.019, n=31 |
|
| Week 48, USG, 1.02, n=31 |
|
| Week 48, USG, 1.025, n=31 |
|
| Week 48, USG, 1.027, n=31 |
|
| Week 48, USG, 1.03, n=31 |
|
| Week 48, UU, 1+, n=31 |
|
| Week 48, UU, 0.1, n=31 |
|
| Week 48, UU, 1, n=31 |
|
| Week 48, UU, 2, n=31 |
|
| Week 48, UU, 3, n=31 |
|
| Week 48, UU, Neg, n=31 |
|
| Week 48, UU, trace, n=31 |
|
| Week 48, UU, normal, n=31 |
|
| Withdrawal, UB, 1+, n=10 |
|
| Withdrawal, UB, (-), n=10 |
|
| Withdrawal, UB, Neg, n=10 |
|
| Withdrawal, UOB, 1+, n=10 |
|
| Withdrawal, UOB, (-), n=10 |
|
| Withdrawal, UOB, Neg, n=10 |
|
| Withdrawal, UG, (-), n=10 |
|
| Withdrawal, UG, Neg, n=10 |
|
| Withdrawal, UK, (-), n=10 |
|
| Withdrawal, UK, Neg, n=10 |
|
| Withdrawal, pH, 5, n=10 |
|
| Withdrawal, pH, 6, n=10 |
|
| Withdrawal, pH, 6.5, n=10 |
|
| Withdrawal, pH, 7, n=10 |
|
| Withdrawal, UP, Neg, n=10 |
|
| Withdrawal, UP, trace, n=10 |
|
| Withdrawal, USG, 1.002, n=10 |
|
| Withdrawal, USG, 1.009, n=10 |
|
| Withdrawal, USG, 1.01, n=10 |
|
| Withdrawal, USG, 1.017, n=10 |
|
| Withdrawal, USG, 1.018, n=10 |
|
| Withdrawal, USG, 1.019, n=10 |
|
| Withdrawal, USG, 1.021, n=10 |
|
| Withdrawal, USG, 1.023, n=10 |
|
| Withdrawal, USG, 1.025, n=10 |
|
| Withdrawal, UU, 1+, n=10 |
|
| Withdrawal, UU, 1, n=10 |
|
| Withdrawal, UU, Neg, n=10 |
|
| Withdrawal, UU, trace, n=10 |
|
| Withdrawal, UU, normal, n=10 |
|
| Title | Measurements |
|---|---|
|
| FU Baseline, UOB, 3+ |
|
| FU Baseline, UOB, (-) |
|
| FU Baseline, UOB, Neg. |
|
| FU Baseline, UG, (-) |
|
| FU Baseline, UG, Neg |
|
| FU Baseline, UK, (-) |
|
| FU Baseline, UK, Neg. |
|
| FU Baseline, pH, 5 |
|
| FU Baseline, pH, 5.5 |
|
| FU Baseline, pH, 6 |
|
| FU Baseline, pH, 6.5 |
|
| FU Baseline, pH, 7 |
|
| FU Baseline, pH, 8 |
|
| FU Baseline, UP, (-) |
|
| FU Baseline, UP, 10 |
|
| FU Baseline, UP, Neg |
|
| FU Baseline, UP, trace |
|
| FU Baseline, USG, 1.002 |
|
| FU Baseline, USG, 1.005 |
|
| FU Baseline, USG, 1.007 |
|
| FU Baseline, USG, 1.009 |
|
| FU Baseline, USG, 1.01 |
|
| FU Baseline, USG, 1.011 |
|
| FU Baseline, USG, 1.012 |
|
| FU Baseline, USG, 1.013 |
|
| FU Baseline, USG, 1.014 |
|
| FU Baseline, USG, 1.015 |
|
| FU Baseline, USG, 1.016 |
|
| FU Baseline, USG, 1.017 |
|
| FU Baseline, USG, 1.018 |
|
| FU Baseline, USG, 1.019 |
|
| FU Baseline, USG, 1.02 |
|
| FU Baseline, USG, 1.021 |
|
| FU Baseline, USG, 1.024 |
|
| FU Baseline, USG, 1.025 |
|
| FU Baseline, USG, 1.027 |
|
| FU Baseline, USG, 1.03 |
|
| FU Baseline, UU, 1+ |
|
| FU Baseline, UU, 0.1 |
|
| FU Baseline, UU, 1 |
|
| FU Baseline, UU, 2 |
|
| FU Baseline, UU, 3 |
|
| FU Baseline, UU, Neg |
|
| FU Baseline, UU, trace |
|
| FU Baseline, UU, normal |
|
| FU Week 24, UB, (-) |
|
| FU Week 24, UB, Neg. |
|
| FU Week 24, UOB, 1+ |
|
| FU Week 24, UOB, 3+ |
|
| FU Week 24, UOB, (-) |
|
| FU Week 24, UOB, Neg. |
|
| FU Week 24, UOB, Trace |
|
| FU Week 24, UG, 1+ |
|
| FU Week 24, UG, (-) |
|
| FU Week 24, UG, 0.2 |
|
| FUWeek 24, UG, Neg |
|
| FU Week 24, UK, (-) |
|
| FU Week 24, UK, Neg. |
|
| FU Week 24, UK, Trace. |
|
| FU Week 24, pH, 5 |
|
| FU Week 24, pH, 5.5 |
|
| FU Week 24, pH, 6 |
|
| FU Week 24, pH, 6.5 |
|
| FU Week 24, pH, 7 |
|
| FU Week 24, pH, 7.5 |
|
| FU Week 24, UP, (-) |
|
| FU Week 24, UP, Neg |
|
| FU Week 24, UP, Trace |
|
| FU Week 24, USG, 1.004 |
|
| FU Week 24, USG, 1.005 |
|
| FU Week 24, USG, 1.008 |
|
| FU Week 24, USG, 1.01 |
|
| FU Week 24, USG, 1.011 |
|
| FU Week 24, USG, 1.012 |
|
| FU Week 24, USG, 1.013 |
|
| FU Week 24, USG, 1.015 |
|
| FU Week 24, USG, 1.016 |
|
| FU Week 24, USG, 1.017 |
|
| FU Week 24, USG, 1.018 |
|
| FU Week 24, USG, 1.019 |
|
| FU Week 24, USG, 1.02 |
|
| FU Week 24, USG, 1.021 |
|
| FU Week 24, USG, 1.022 |
|
| FU Week 24, USG, 1.023 |
|
| FU Week 24, USG, 1.024 |
|
| FU Week 24, USG, 1.025 |
|
| FU Week 24, UU, 0.1 |
|
| FU Week 24, UU, 1 |
|
| FU Week 24, UU, 4 |
|
| FU Week 24, UU, <1.0 |
|
| FU Week 24, UU, Neg |
|
| FU Week 24, UU, Trace |
|
| FUWeek 24, UU, normal |
|
| Title | Measurements |
|---|---|
|
| Antiviral Baseline, normal, n=41 |
|
| Antiviral Baseline, abnormal-NCS, n=41 |
|
| Antiviral Baseline, abnormal-CS, n=41 |
|
| Part 2, week 12, normal, n=36 |
|
| Part 2, week 12, abnormal-NCS, n=36 |
|
| Part 2, week 12, abnormal-CS, n=36 |
|
| Part 2, week 24, normal, n=36 |
|
| Part 2, week 24, abnormal-NCS, n=36 |
|
| Part 2, week 24, abnormal-CS, n=36 |
|
| Part 2, week 36, normal, n=34 |
|
| Part 2, week 36, abnormal-NCS, n=34 |
|
| Part 2, week 36, abnormal-CS, n=34 |
|
| Part 2, week 48, normal, n=31 |
|
| Part 2, week 48, abnormal-NCS, n=31 |
|
| Part 2, week 48, abnormal-CS, n=31 |
|
| Withdrawal, normal, n=14 |
|
| Withdrawal, abnormal-NCS, n=14 |
|
| Withdrawal, abnormal-CS, n=14 |
|
| Worst ECG post Baseline, normal, n=41 |
|
| Worst ECG post Baseline, abnormal-NCS, n=41 |
|
| Worst ECG post Baseline, abnormal-CS, n=41 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, normal |
|
| FU Week 24, abnormal-NCS |
|
| FU Week 24, abnormal-CS |
|
| Title | Measurements |
|---|---|
|
| Baseline, measureable spleen breadth, n=45 |
|
| Baseline, OCSF, n=45 |
|
| Week 24, masses suspicious for HCC detected, n=36 |
|
| Week 24, ascites detected, n=36 |
|
| Week 24, portal vein thrombosis detected, n=36 |
|
| Week 24, measureable spleen breadth, n=36 |
|
| Week 24, OCSF, n=36 |
|
| Week 48, masses suspicious for HCC detected, n=29 |
|
| Week 48, ascites detected, n=29 |
|
| Week 48, portal vein thrombosis detected, n=29 |
|
| Week 48, measureable spleen breadth, n=29 |
|
| Week 48, OCSF, n=29 |
|
| WD/comp, masses suspicious for HCC detected, n=37 |
|
| WD/comp, ascites detected, n=37 |
|
| WD/comp, portal vein thrombosis detected, n=37 |
|
| WD/comp, measureable spleen breadth, n=37 |
|
| WD/comp, OCSF, n=37 |
|
| Title | Measurements |
|---|---|
|
| FU Week 24, measureable spleen breadth |
|
| FU Week 24, OCSF |
|
|
| Week 24, spleen width (breadth), n=34 |
|
| Week 48, spleen length, n=29 |
|
| Week 48, spleen width (breadth), n=29 |
|
| WD/comp, spleen length, n=37 |
|
| WD/comp, spleen width (breadth), n=37 |
|