Purpura, Thrombocytopaenic, Idiopathic
Conditions
Keywords
idiopathic thrombocytopenic purpura, ITP, thrombocytopenia, platelets
Brief summary
This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts. For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov
Interventions
DRUGeltrombopag
experimental
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects eligible for enrolment in the study must meet all of the following criteria: * Subject has signed and dated a written inform consent. * Adults (≥18 years) diagnosed with chronic ITP according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, and a platelet count between ≥20 Gi/L and ≤50 Gi/L on Day 1 (or within 24 hours prior to dosing on Day 1). In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g. pseudothrombocytopenia, myelodysplasia). The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP. * Subjects who have previously received one or more prior ITP therapies. Previous treatments for ITP include but are not limited to corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab. * Subjects must have either initially responded (platelet count \>100 Gi/L) to a previous ITP therapy or have had a bone marrow biopsy consistent with ITP within 3 years to rule out myelodysplastic syndromes or other causes of thrombocytopenia. * It is important to clearly differentiate the effect of eltrombopag on platelet count from the treatment effects of prior and concomitant ITP therapies. Therefore: 1. Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 1 week prior to randomization and the platelet count must show a clear downward trend after the last treatment with immunoglobulins. Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to randomization, or clearly be ineffective. 2. Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for a least 4 weeks prior to randomization. Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to randomization. * Prothrombin time and activated partial thromboplastin time must be within 80 to 120% of normal range with no history of hypercoagulable state. * A complete blood count (CBC), within the reference range (including differential not indicative of a disorder other than ITP), with the following exceptions: * Platelet count between ≥20 Gi/L and ≤50 Gi/L on Day 1 (or within 24 hours of Day 1) is required for inclusion. * Hemoglobin: Subjects with hemoglobin levels between 10g/dL (100g/L) and the lower limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss). * Absolute Neutrophil Count (ANC ) \>1500/mL (1.5 x 10\^9/L) is required for inclusion (elevated White Blood Cells/ANC above the reference range due to steroid treatment is acceptable). * The following clinical chemistries MUST NOT exceed the normal reference range by more than 20%: creatinine, Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, total albumin and alkaline phosphatase. * Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal \>1 year), or of childbearing potential and use of one of the following acceptable methods of contraception from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: Complete abstinence from intercourse; Intrauterine device (IUD); Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); Male partner is sterile prior to entry into the study and is the only partner of the female; Systemic contraceptives (combined or progesterone only). * Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned.
Exclusion criteria
A subject will NOT be eligible for inclusion in this study if any of the following criteria apply: * Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g., thrombocytopenia is secondary to another disease). * Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy. * Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, Antithrombin III deficiency, etc), or any other family history of arterial or venous thrombosis. * Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc \>450 msec. * Female subjects who are nursing or pregnant (positive serum or urine b-human chorionic gonadotrophin pregnancy test) at screening or pre-dose on Day 1. * History of alcohol/drug abuse. * Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication. * Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or Non Steroidal Anti Inflammatory Drugs) or anti-coagulants for \> 3 consecutive days within 2 weeks of the study start and until the end of the study. * History of platelet agglutination abnormality that prevents reliable measurement of platelet counts. * All subjects with secondary immune thrombocytopenia, including those with laboratory or clinical evidence of human immunodeficiency virus (HIV) infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence for active hepatitis at the time of subject screening. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections. * Previous participation in a clinical study with eltrombopag. * Subjects planning to have cataract surgery. * In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Day 42 of each cycle | Complete blood count, platelet count by blood draw |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Up to 1 year | Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment. |
| Number of Participants Who Required Rescue Medication | Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag | New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy |
| Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | Up to 42 days of dosing | CBC, platelet counts |
| Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4) | World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss. |
| Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4) | ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding |
| Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | Up to 1 year | Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa |
Countries
Germany, Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1). | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Cycle 1: Eltrombopag 50 mg Starting Dose | Adverse Event | 1 |
| Cycle 1: Eltrombopag 50 mg Starting Dose | Lack of Efficacy | 8 |
| Cycle 1: Eltrombopag 50 mg Starting Dose | Prolonged Response | 1 |
| Cycle 1: Eltrombopag 50 mg Starting Dose | Relocation | 1 |
| Cycle 2: Eltrombopag 50 or 75 mg | Lack of Efficacy | 2 |
| Cycle 2: Eltrombopag 50 or 75 mg | Prolonged Response | 1 |
| Cycle 2: Eltrombopag 50 or 75 mg | Withdrawal by Subject | 1 |
| Cycle 3: Eltrombopag 50 or 75 mg | Lack of Efficacy | 1 |
| Cycle 3: Eltrombopag 50 or 75 mg | Physician Decision | 1 |
| Cycle 3: Eltrombopag 50 or 75 mg | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age Continuous | 49.6 years STANDARD_DEVIATION 14.61 |
| Baseline Platelet Count 20 Gi/L to 30 Gi/L | 29 participants |
| Baseline Platelet Count Greater than 30 Gi/L to 50 Gi/L | 31 participants |
| Baseline Platelet Count Greater than 50 Gi/L | 2 participants |
| Baseline Platelet Count Less than 20 giga per liter (Gi/L) | 4 participants |
| Baseline Splenectomy Status No | 46 participants |
| Baseline Splenectomy Status Yes | 20 participants |
| Race/Ethnicity, Customized African American/African | 2 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian - East Asian | 10 participants |
| Race/Ethnicity, Customized White - Arabic/North African | 6 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 47 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 21 Participants |
| Use of Idiopathic Thrombocytopenic Purpura Medication at Baseline No | 44 participants |
| Use of Idiopathic Thrombocytopenic Purpura Medication at Baseline Yes | 22 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 66 | 30 / 55 | 38 / 51 | 17 / 66 | 7 / 66 | 55 / 66 |
| serious Total, serious adverse events | 0 / 66 | 1 / 55 | 0 / 51 | 1 / 66 | 1 / 66 | 4 / 66 |
Outcome results
Primary
Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1
Complete blood count, platelet count by blood draw
Time frame: Day 42 of each cycle
Population: Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Responders | 52 participants |
| Cycle 1 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Non-responders | 0 participants |
| Cycle 2 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Responders | 41 participants |
| Cycle 2 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Non-responders | 10 participants |
| Cycle 3 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Responders | 38 participants |
| Cycle 3 | Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 | Non-responders | 11 participants |
95% CI: [0.74, 0.94]
Secondary
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa
Time frame: Up to 1 year
Population: Safety Population: any participant who received at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | Baseline | 12 participants |
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | Cycle 2 on-therapy | 6 participants |
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | Cycle 3 on-therapy | 7 participants |
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | 4-week follow-up | 8 participants |
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | 3-month follow-up | 1 participants |
| Cycle 1 | Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up | 6-month follow-up | 3 participants |
Secondary
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.
Time frame: Up to 1 year
Population: Intent-to-Treat (ITT) Population: All participants who were dispensed study medication
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cycle 1 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest off-therapy platelet count | 118.5 Gi/L |
| Cycle 1 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest on-therapy platelet count | 72.0 Gi/L |
| Cycle 1 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Baseline platelet count | 33.0 Gi/L |
| Cycle 1 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest on-therapy platelet count | 200.5 Gi/L |
| Cycle 1 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest off-therapy platelet count | 21.0 Gi/L |
| Cycle 2 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest on-therapy platelet count | 67.5 Gi/L |
| Cycle 2 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Baseline platelet count | 25.0 Gi/L |
| Cycle 2 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest on-therapy platelet count | 196.0 Gi/L |
| Cycle 2 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest off-therapy platelet count | 92.5 Gi/L |
| Cycle 2 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest off-therapy platelet count | 22.5 Gi/L |
| Cycle 3 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest off-therapy platelet count | 22.0 Gi/L |
| Cycle 3 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest off-therapy platelet count | 125.0 Gi/L |
| Cycle 3 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Baseline platelet count | 26.0 Gi/L |
| Cycle 3 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Lowest on-therapy platelet count | 59.0 Gi/L |
| Cycle 3 | Changes in Participants' Platelet Counts During 3 Cycles of Treatment | Highest on-therapy platelet count | 174.0 Gi/L |
Secondary
Number of Participants Who Required Rescue Medication
New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy
Time frame: Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Number of Participants Who Required Rescue Medication | Participants who required rescue treatment | 2 participants |
| Cycle 1 | Number of Participants Who Required Rescue Medication | Participants who did not require rescue treatment | 64 participants |
| Cycle 2 | Number of Participants Who Required Rescue Medication | Participants who required rescue treatment | 2 participants |
| Cycle 2 | Number of Participants Who Required Rescue Medication | Participants who did not require rescue treatment | 53 participants |
| Cycle 3 | Number of Participants Who Required Rescue Medication | Participants who required rescue treatment | 10 participants |
| Cycle 3 | Number of Participants Who Required Rescue Medication | Participants who did not require rescue treatment | 41 participants |
Secondary
Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.
CBC, platelet counts
Time frame: Up to 42 days of dosing
Population: Cycle 1 responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | At least 80 percent of assessments met criteria | 38 participants |
| Cycle 1 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | Less than 80 percent of assessments met criteria | 10 participants |
| Cycle 2 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | At least 80 percent of assessments met criteria | 35 participants |
| Cycle 2 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | Less than 80 percent of assessments met criteria | 10 participants |
| Cycle 3 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | At least 80 percent of assessments met criteria | 30 participants |
| Cycle 3 | Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. | Less than 80 percent of assessments met criteria | 13 participants |
Secondary
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding
Time frame: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)
Population: Participants who responded in Cycle 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0 (Day 1), n | 50 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0 (Day 1), n | 50 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 0 | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 1 | 14 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 2 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 1 | 16 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1 (Day 8), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 2 | 3 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4 (Day 29), n | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 0 | 6 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4 (Day 29), n | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 0 | 39 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0 (Day 1), n | 50 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 2 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 1 | 11 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 0 | 30 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 1 | 11 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 2 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 1 | 10 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 0 | 16 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2 (Day 15), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3 (Day 22), n | 29 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 0 | 42 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 2 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 1 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 0 | 35 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 1 | 9 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 0 | 26 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2 (Day 15), n | 36 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 0 | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 0 | 27 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 1 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 0 | 23 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 1 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5 (Day 36), n | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 0 | 42 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4 (Day 29), n | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1 (Day 1), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 0 | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6 (Day 43), n | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 1 | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 0 | 27 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 1 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 0 | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 0 | 20 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5 (Day 36), n | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6 (Day 43), n | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 0 | 25 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 1 | 3 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3 (Day 22), n | 29 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2 (Day 15), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 0 | 27 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6 (Day 43), n | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 2 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5 (Day 36), n | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 0 | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 0 | 40 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 0 | 30 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1 (Day 8), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4 (Day 29), n | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 0 | 45 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 1 | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4 (Day 29), n | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 0 | 36 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 0 | 33 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2 (Day 15), n | 36 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 0 | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 1 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2 (Day 15), n | 36 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 1 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 0 | 46 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3 (Day 22), n | 29 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2 (Day 15), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 0 | 27 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 0 | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 0 | 49 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4 (Day 29), n | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 0 | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 1 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 1 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 0 | 41 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 1 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 0 | 45 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 0 | 46 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0 (Day 1), n | 52 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 0 | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 1 | 17 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 0 | 46 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 1 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 2 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 0 | 43 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3 (Day 22), n | 32 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 0 | 28 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 1 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4 (Day 29), n | 28 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 0 | 24 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 1 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5 (Day 36), n | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 0 | 21 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 1 | 5 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6 (Day 43), n | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 0 | 23 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1 (Day 8), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 0 | 39 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 1 | 6 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2 (Day 15), n | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 0 | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 1 | 5 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3 (Day 22), n | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 0 | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 1 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4 (Day 29), n | 12 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 0 | 12 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 1 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0 (Day 1), n | 52 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 0 | 27 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 1 | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 0 | 37 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 1 | 13 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 2 | 1 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 0 | 38 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 1 | 7 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3 (Day 22), n | 32 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 0 | 24 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 1 | 8 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4 (Day 29), n | 28 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 0 | 24 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 1 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5 (Day 36), n | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 0 | 23 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 1 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6 (Day 43), n | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 0 | 22 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 1 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1 (Day 1), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 0 | 38 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 1 | 7 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2 (Day 15), n | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 0 | 24 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 1 | 11 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3 (Day 22), n | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 0 | 20 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 1 | 9 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 2 | 1 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4 (Day 29), n | 12 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 0 | 9 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 1 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0 (Day 1), n | 52 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 0 | 46 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 1 | 5 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 2 | 1 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 0 | 49 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 0 | 43 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3 (Day 22), n | 32 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 0 | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4 (Day 29), n | 28 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 0 | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5 (Day 36), n | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 0 | 24 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6 (Day 43), n | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 0 | 23 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1 (Day 8), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 0 | 43 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2 (Day 15), n | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 0 | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 1 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3 (Day 22), n | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 0 | 29 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 1 | 1 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4 (Day 29), n | 12 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 0 | 10 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 1 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0 (Day 1), n | 49 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 0 | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0 (Day 1), n | 49 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 0 | 32 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 0 | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 1 | 6 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 1 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4, Grade 0 | 41 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 1 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 0, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 4 (Day 29), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1 (Day 8), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 0 | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 1 | 7 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 1 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3, Grade 0 | 39 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 3 (Day 22), n | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2 (Day 15), n | 42 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 0 | 41 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 1 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 1 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 1 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2, Grade 0 | 40 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 1 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 0 | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2, Grade 0 | 39 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 0 | 31 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 1 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4 (Day 29), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 1 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1, Grade 0 | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 1 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, off-therapy, Week 1 (Day 8), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 2 (Day 15), n | 42 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4 (Day 29), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 1 | 10 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 0 | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 1 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 1 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6, Grade 0 | 27 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 6 (Day 43), n | 27 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0 (Day 1), n | 49 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5 (Day 36), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3 (Day 22), n | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 0 | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 1 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 1 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 1 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 0 | 25 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 1 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 5 (Day 36), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5, Grade 0 | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6 (Day 43), n | 27 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 4, Grade 0 | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 0 | 25 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 1 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 5, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 1 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4, Grade 0 | 25 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 5 (Day 36), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 4 (Day 29), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 0 | 41 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1 (Day 1), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6 (Day 43), n | 27 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 0 | 43 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 1 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 1 | 5 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3, Grade 0 | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1, Grade 0 | 44 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 1, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 0 | 26 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 1 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 0 | 36 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 1 | 9 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 0, Grade 0 | 39 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 1 | 9 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2, Grade 0 | 32 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 1 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 2, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 2 (Day 15), n | 42 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4, Grade 0 | 28 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3 (Day 22), n | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 4 (Day 29), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 0 | 31 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 1 | 12 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, on-therapy, Week 6, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 1 | 13 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1, Grade 0 | 35 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 2 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 3, Grade 2 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 1 (Day 8), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 3, Grade 1 | 5 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4 (Day 29), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 2 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Oral, off-therapy, Week 1 (Day 8), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 0 | 31 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 1 | 12 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 3, Grade 1 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 1 | 15 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, on-therapy, Week 0, Grade 0 | 36 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, petechiae, on-therapy, Week 1 (Day 8), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score | Skin, ecchymosis, off-therapy, Week 4, Grade 2 | 2 participants |
Secondary
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.
Time frame: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)
Population: Participants who responded in Cycle 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grade 0 | 35 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 2-4 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 1-4 | 3 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2 (Day 15), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4 (Day 29), n | 7 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 2-4 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 1-4 | 8 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grade 0 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 1-4 | 10 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 2-4 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 1-4 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grade 0 | 22 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 1-4 | 17 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 2-4 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 0 | 23 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grade 0 | 34 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0 (Day 1), n | 52 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 2-4 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grade 0 | 26 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 1-4 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 2-4 | 10 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 1-4 | 26 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4 (Day 29), n | 31 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2 (Day 15), n | 37 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 2-4 | 0 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 2-4 | 3 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grade 0 | 26 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6 (Day 43), n | 25 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 1-4 | 5 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 1-4 | 11 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grade 0 | 24 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grade 0 | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 2-4 | 2 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1 (Day 8), n | 47 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3 (Day 22), n | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 2-4 | 1 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 2-4 | 4 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grade 0 | 18 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5 (Day 36), n | 28 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 1-4 | 12 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 1-4 | 10 participants |
| Cycle 1 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grade 0 | 37 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 2-4 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6 (Day 43), n | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grade 0 | 22 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 1-4 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 2-4 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1 (Day 8), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grade 0 | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 1-4 | 10 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 2-4 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2 (Day 15), n | 35 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grade 0 | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 1-4 | 10 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 2-4 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3 (Day 22), n | 30 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grade 0 | 19 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 1-4 | 11 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 2-4 | 4 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4 (Day 29), n | 12 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grade 0 | 9 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 1-4 | 3 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 2-4 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0 (Day 1), n | 52 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grade 0 | 21 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 1-4 | 31 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 2-4 | 10 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1 (Day 8), n | 51 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grade 0 | 36 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 1-4 | 15 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grade 0 | 38 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 1-4 | 7 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 2-4 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3 (Day 22), n | 32 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grade 0 | 25 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 1-4 | 7 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 2-4 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4 (Day 29), n | 28 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 0 | 22 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 1-4 | 6 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 2-4 | 2 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5 (Day 36), n | 26 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grade 0 | 20 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 1-4 | 6 participants |
| Cycle 2 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 2-4 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 1-4 | 5 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grade 0 | 32 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grade 0 | 30 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 2-4 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 1-4 | 11 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3 (Day 22), n | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1 (Day 8), n | 46 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2, Grades 2-4 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 2-4 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grade 0 | 22 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3 (Day 22), n | 33 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grades 1-4 | 15 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5 (Day 36), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grade 0 | 26 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2, Grade 0 | 30 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 2-4 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 1-4 | 7 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 2 (Day 15), n | 45 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6 (Day 43), n | 27 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 3, Grades 2-4 | 2 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 2-4 | 0 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grade 0 | 24 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4 (Day 29), n | 29 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grades 1-4 | 4 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 1-4 | 17 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grade 0 | 32 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 6, Grades 1-4 | 5 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0, Grades 2-4 | 6 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 0 (Day 1), n | 49 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 0 | 24 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1 (Day 8), n | 49 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 2-4 | 6 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 5, Grades 2-4 | 1 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grade 0 | 37 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grades 1-4 | 18 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 4, Grade 1-4 | 5 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 1-4 | 12 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4, Grade 0 | 30 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 4 (Day 29), n | 48 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 1, Grades 2-4 | 3 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 2-4 | 7 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 1, Grade 0 | 42 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | On-therapy, Week 2 (Day 15), n | 43 participants |
| Cycle 3 | Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale | Off-therapy, Week 3, Grades 1-4 | 16 participants |