A Study to Investigate the Efficacy and Safety of Lusutro... | NCT01054443

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo tablets orally once a day for 42 days.	Drug: Placebo
Lusutrombopag 0.5 mg	Experimental	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.	Drug: Lusutrombopag
Lusutrombopag 0.75 mg	Experimental	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.	Drug: Lusutrombopag
Lusutrombopag 1.0 mg	Experimental	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.	Drug: Lusutrombopag

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Tablet	Placebo
Lusutrombopag

Measure	Description	Time Frame
Percentage of Participants With a Response	Responders were participants with one of the following: achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or prematurely withdrawn due to a platelet count > 400,000 cells/µL prior to Day 42. Participants were counted as non-responders if any of the following conditions held: The above conditions were not satisfied; They received rescue medications; They satisfied the above conditions after receiving restricted medications during the treatment period; They had achieved a platelet count of ≥ 50,000 cells/µL before Week 6 but not after Week 6; or They withdrew for any reason other than a platelet count > 400,000 cells/µL.	Week 6

Measure	Description	Time Frame
Change From Baseline in Platelet Count at Week 6		Baseline and Week 6
Duration of Response	Duration of response was defined as the percentage of the cumulative time a platelet count was ≥ 50,000 cells/µL during the treatment period.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A signed and dated written informed consent
Males and females ≥ 18 years of age
All subjects must agree to use barrier contraception
Diagnosis of ITP
Subjects > 60 years must have had a diagnostic bone marrow aspiration
Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs
Subjects receiving steroid therapy must be on a stable dose
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN)
Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1)

Exclusion Criteria:

History of clinically important hemorrhagic clotting disorder
Females who are pregnant, lactating, or taking oral contraceptives
History of alcohol/drug abuse or dependence within 1 year
Use of the following drugs or treatment prior to Visit 1 (Day 1):
- Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
- Within 8 weeks - rituximab
- Within 2 weeks - platelet transfusions or plasmapheresis treatment
- Within 4 weeks - use of anti-platelet or anti-coagulant drugs
- Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin
History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Screening
Splenectomy within 4 weeks prior to Screening
Clinically significant laboratory abnormalities
- Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP
- Absolute neutrophil count < 1000/mm^3
- Abnormal peripheral blood smear
- Total bilirubin > 1.5 x upper limit of normal
- Alanine aminotransferase (ALT) > 1.5 x upper limit of normal
- Aspartate aminotransferase (AST) > 1.5 x upper limit of normal
- Creatinine > 1.5 x upper limit of normal
- Human immunodeficiency virus (HIV) positive
- Hepatitis A immunoglobulin M antibody (IgM HAV) positive, hepatitis B surface antigen (HbsAg) or hepatitis C antibody (HCV) positive
- Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal
- Free thyroxine (T4) > 1.5 x upper limit of normal
Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Screening
Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
Exposure to an investigative medication within the past 30 days

Name	Affiliation	Role
Shionogi Clinical Trials Administrator Clinical Support Help Line	Shionogi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigator		Anaheim	California	92801	United States
Investigator

ID	Title	Description
FG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
FG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.

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

Percentage of Participants With a Response

Responders were participants with one of the following:

achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or
prematurely withdrawn due to a platelet count > 400,000 cells/µL prior to Day 42.

Participants were counted as non-responders if any of the following conditions held:

The above conditions were not satisfied;
They received rescue medications;
They satisfied the above conditions after receiving restricted medications during the treatment period;
They had achieved a platelet count of ≥ 50,000 cells/µL before Week 6 but not after Week 6; or
They withdrew for any reason other than a platelet count > 400,000 cells/µL.

The full analysis set included all randomized participants who received at least 1 dose of study drug and had a platelet count at Baseline and at least 1 platelet count after randomized study drug was taken.

Posted

Number

95% Confidence Interval

percentage of participants

Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts
Participants	OG0005 OG0015 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.0(NA to NA)Could not be estimated when number of responses = 0 OG00120.0(0.5 to 71.6) OG0020.0(NA to NA)Could not be estimated when number of responses = 0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.	Cochran-Armitage Trend Test		0.431		Cochran-Armitage Trend Test Statistic	0.173											Other

Secondary

Change From Baseline in Platelet Count at Week 6

Full analysis set participants who completed 6 weeks of treatment.

Posted

Least Squares Mean

Standard Error

cells/µL

Baseline and Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts
Participants

Secondary

Duration of Response

Duration of response was defined as the percentage of the cumulative time a platelet count was ≥ 50,000 cells/µL during the treatment period.

Participants in the full analysis set with platelet counts ≥ 50,000 cells/μL at any time during the 6-week treatment period.

Posted

Median

Full Range

percentage of days

6 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Secondary

Percentage of Participants Who Achieved a Platelet Count of ≥ 30,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing

Participants in the full analysis set who completed 6 weeks of treatment

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts

Secondary

Percentage of Participants Who Achieved a Platelet Count of ≥ 50,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing

Participants in the full analysis set who completed 6 weeks of treatment

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts

Secondary

Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,

Bleeding assessments were performed by the Investigator according to the World Health Organization (WHO) criteria bleeding scale:

Grade 0: no bleeding; Grade 1: petechial bleeding; Grade 2: mild blood loss (clinically significant); Grade 3: gross blood loss, requires transfusion (severe); Grade 4: debilitating blood loss, retinal or cerebral associated with fatality.

For each participant, the most severe WHO bleeding grade observed during the 6-week treatment period is reported.

Full analysis set

Posted

Count of Participants

Participants

6 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg

Secondary

Number of Participants Who Received Rescue Medication During the Treatment Period

Full analysis set

Posted

Count of Participants

Participants

6 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent.

A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.

A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.

The safety population included all participants who received at least 1 dose of study drug

Posted

Count of Participants

Participants

6 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
OG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.

Secondary

Lusutrombopag Plasma Concentration

Plasma concentrations of lusutrombopag were determined using a validated liquid chromatography mass spectrometry method. The lower limit of quantification (LOQ) for the plasma assay for lusutrombopag was 0.1 ng/mL.

Participants who received at least 1 dose of study drug

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Days 8, 22, and 36, after dosing

ID	Title	Description
OG000	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG001	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts
Participants

Secondary

Plasma Concentration of Metabolite S-888711 Deshexyl

Plasma concentrations of the major metabolite S-888711 deshexyl were determined using a validated liquid chromatography mass spectrometry method. The lower limit of quantification (LOQ) for the plasma assay for S-888711 deshexyl was 0.1 ng/mL.

Participants who received at least 1 dose of study drug, with available data at each time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Days 8, 22, and 36, after dosing

ID	Title	Description
OG000	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
OG001	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
OG002	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG0031 affected5 at risk
Dry mouth	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Infrequent bowel movements	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Cyst	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Fatigue	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Inflammation	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Oedema	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Vessel puncture site haemorrhage	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Muscle spasms	General disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0013 affected5 at risk EG0020 affected5 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0021 affected5 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Clumsiness	Nervous system disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Blood glucose increased	Investigations	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Hot flush	Vascular disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Vision blurred	Eye disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Amenorrhoea	Reproductive system and breast disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 12.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Victim of sexual abuse	Social circumstances	MedDRA Version 12.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic
D001791	Blood Platelet Disorders
D013921	Thrombocytopenia
D006402	Hematologic Diseases
D011697	Purpura, Thrombotic Thrombocytopenic

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006425	Hemic and Lymphatic Diseases
D057049	Thrombotic Microangiopathies
D000095542	Cytopenia
D006474	Hemorrhagic Disorders
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012877	Skin Manifestations
D012816	Signs and Symptoms
D019851	Thrombophilia

ID	Title	Description
BG000	Placebo	Participants received placebo tablets orally once a day for 42 days.
BG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
BG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
BG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo tablets orally once a day for 42 days.	5	0	5	4	5
EG001	Lusutrombopag 0.5 mg	Participants received 0.5 mg lusutrombopag orally once a day for 42 days.	5	0	5	5	5
EG002	Lusutrombopag 0.75 mg	Participants received 0.75 mg lusutrombopag orally once a day for 42 days.	5	0	5	5	5
EG003	Lusutrombopag 1.0 mg	Participants received 1.0 mg lusutrombopag orally once a day for 42 days.	5	1	5	4	5