Clinical Trial for Non-responders Who Previously Particip... | NCT00996216

Label	Type	Description	Intervention Names
Open-label eltrombopag	Experimental	Open-label eltrombopag with dose titrations to support adequate platelet counts.	Drug: Eltrombopag Drug: Antiviral therapy

Name	Type	Description	Arm Group Labels	Other Names
Eltrombopag	Drug	Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1	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, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.	From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
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, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.	From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1

Secondary Outcomes

Measure	Description	Time Frame
Platelet Counts at the Indicated Time Points	Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.	From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		San Diego	California	92123	United States
GSK Investigational Site

ID	Title	Description
FG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

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

Secondary

Platelet Counts at the Indicated Time Points

Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.

Pre-antiviral Safety Population

Posted

Mean

Standard Deviation

Gi/L

From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Units	Counts
Participants	OG00027

Title

Denominators

Categories

Screening, n=27

Title	Measurements
	OG00053.1± 12.90

Part 1/Day 1, n=27

Title	Measurements
	OG00055.9± 18.69

Part 1/Week 1, n=25

Secondary

Number of Particpants Who Initiated Antiviral Therapy

The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.

Pre-antiviral Safety Population

Posted

Number

Participants

From the start of the investigational product up to 9 weeks (median of 21 days)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Units	Counts

Primary

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1

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, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.

Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study

Posted

Number

Participants

From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With Any AE and Any SAE in Part 2

Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy

Posted

Number

Participants

From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1

Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Posted

Number

Participants

From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2

Antiviral Safety Population

Posted

Number

Participants

From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1

Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Posted

Number

Participants

From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2

Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Antiviral Safety Population

Posted

Number

Participants

From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2

Visual acuity (VA) is defined as acuteness or clearness of vision.

Entire Safety Population: all participants in the Pre-antiviral Safety Population

Posted

Number

Participants

From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Units	Counts

Primary

Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2

LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.

Entire Safety Population

Posted

Number

Participants

From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Primary

Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2

Entire Safety Population

Posted

Number

Participants

From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Secondary

Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)

SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.

Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.

Posted

Number

Participants

From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

ID	Title	Description
OG000	Eltrombopag	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected27 at risk EG0017 affected25 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0011 affected25 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0012 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0013 affected25 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0012 affected25 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0011 affected25 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Hypertrophy of tongue papillae	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected27 at risk EG0017 affected25 at risk
Parkinsonism	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Disturbance in attention	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Hyperaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Myoclonic epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0016 affected25 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0013 affected25 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0017 affected25 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0012 affected25 at risk
Viral rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Furuncle	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected27 at risk EG0013 affected25 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0011 affected25 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0015 affected25 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0019 affected25 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0017 affected25 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0015 affected25 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Injection site pruritus	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Blood bilirubin increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
White blood cell count decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0011 affected25 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Sleep disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Aggression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Anger	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Depressed mood	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Mood swings	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Nervousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Eye discharge	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Retinal exudates	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Retinal haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Visual acuity reduced	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Nocturia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Pallor	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0014 affected25 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0013 affected25 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0012 affected25 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected27 at risk EG0011 affected25 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected27 at risk EG0010 affected25 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eltrombopag (Part 1)	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.			0	27	9	27
EG001	Eltrombopag (Part 2)	Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.			5	25	25	25

ID	Term
D006526	Hepatitis C
D013921	Thrombocytopenia
C537560	Jacobs syndrome