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The present study will be conducted to evaluate the efficacy and safety of AMG531 and to determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. Its efficacy and safety during the extension period beyond one year will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG531 (Dose 1) | Experimental |
| |
| AMG531 (Dose 2) | Experimental |
| |
| AMG531 (Dose 3) | Experimental |
| |
| AMG531 (Dose 4) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG531 | Drug | Subcutaneous, weekly injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving a Platelet Response at Week 9 | The proportion of subjects achieving a platelet response at Week 9, and two-sided 95% confidence interval will be calculated. Platelet response is defined as 1) achieving absolute platelet increase of ≥ 20x10^9/L above baseline or 2) increase to ≥ 10x10^9/L and by at least 100% from baseline. | At week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving a Platelet Response | The proportion of subjects with a platelet response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104 and Week 1 through Week 156. | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea, Republic of | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40593138 | Derived | Jang JH, Mitani K, Tomiyama Y, Miyazaki K, Nagafuji K, Usuki K, Uoshima N, Fujisaki T, Kosugi H, Matsumura I, Sasaki K, Kizaki M, Sawa M, Hidaka M, Kobayashi N, Ichikawa S, Yonemura Y, Murotani K, Shimizu M, Matsuda A, Ozawa K, Nakao S, Lee JW. Predictive factors of romiplostim response in patients with refractory aplastic anemia: data from two clinical trials. Ann Hematol. 2025 Aug;104(8):4003-4011. doi: 10.1007/s00277-025-06337-7. Epub 2025 Jul 1. | |
| 31474546 |
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Subjects were enrolled from 14 April 2014 through 28 November 2014 from two clinical centers (Seoul St. Mary's Hospital and Samsung Medical Center, Seoul, South Korea).
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG531 (Dose 1) | AMG531: 1 μg/kg, subcutaneous, once weekly |
| FG001 | AMG531 (Dose 2) | AMG531: 3 μg/kg, subcutaneous, once weekly |
| FG002 | AMG531 (Dose 3) | AMG531: 6 μg/kg, subcutaneous, once weekly |
| FG003 | AMG531 (Dose 4) | AMG531: 10 μg/kg, subcutaneous, once weekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | AMG531 (Dose 1) | AMG531: 1 μg/kg, subcutaneous, once weekly |
| BG001 | AMG531 (Dose 3) | AMG531: 3 μg/kg, subcutaneous, once weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Achieving a Platelet Response at Week 9 | The proportion of subjects achieving a platelet response at Week 9, and two-sided 95% confidence interval will be calculated. Platelet response is defined as 1) achieving absolute platelet increase of ≥ 20x10^9/L above baseline or 2) increase to ≥ 10x10^9/L and by at least 100% from baseline. | All efficacy analyses were carried out using the Per Protocol Set, which was defined as all enrolled subjects who received ≥6 times of the specified dose, with no major violation in the initial dose evaluation period. The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because the Participant Flow module has been recorded based on the Full Analysis Set. | Posted | Count of Participants | Participants | At week 9 |
|
Up to 3 years
This section focuses primarily on treatment-emergent AEs (TEAEs), defined as any untoward medical occurrence in subjects who received AMG531. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease, regardless of causal relationship to AMG531.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMG531 (Dose 1) | AMG531: Subcutaneous, weekly injection | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Team, Clinical Development Department | Kyowa Kirin Korea Co. Ltd., | 82221912918 | kyungmo.lee.m6@kyowakirin.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2016 | Nov 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| C537560 | Jacobs syndrome |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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| Proportion of Subjects Achieving Platelet Transfusion Independency | The proportion of subjects achieving platelet transfusion independency in any time during the initial dose evaluation period , Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated). Platelet transfusion independence is defined as achieving transfusion free period of at least 8 consecutive weeks (56 days). | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
| Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response | The proportion of subjects with erythroid response, neutrophil response and erythroid and/or neutrophil response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated). | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
| Duration of Platelet Response and Time to Platelet Response | For subjects with a platelet response in any time, time to the initial platelet response and duration of platelet response will be summarized Time to the initial platelet response will be calculated as sampling date (response achieved) minus first dose date of study drug plus 1. Duration of platelet response will be calculated as the maximum of the duration of platelet response for each subject, each duration of response calculated as the date when response is disappeared minus the date when response is achieved. The censoring date is defined as the date of the last Platelet examination or EOS whichever archives first. | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
| Proportion of Subjects Achieving Tri-lineage Responses | Tri-lineage response is defined in those achieving platelet response, erythroid response, and neutrophil response all together. The proportion of subjects with tri-lineage response will be calculated in the same manner as the primary variables. Time to tri-lineage response will be summarized in the same manner as time to platelet response. Time to tri-lineage response is defined as duration of the time from Day 1 to the date of platelet response, erythroid response or neutrophil response whichever achieves last in Visit. | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 157 |
| Duration of Study Drug Discontinuation While Maintaining Stable Response | The longest duration of study drug discontinuation in subjects while maintaining a stable response is summarized | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
| Derived |
| Lee JW, Lee SE, Jung CW, Park S, Keta H, Park SK, Kim JA, Oh IH, Jang JH. Romiplostim in patients with refractory aplastic anaemia previously treated with immunosuppressive therapy: a dose-finding and long-term treatment phase 2 trial. Lancet Haematol. 2019 Nov;6(11):e562-e572. doi: 10.1016/S2352-3026(19)30153-X. Epub 2019 Aug 29. |
| Eligibility criteria |
|
| No responder |
|
| Unable to conduct observations or assess |
|
| Withdrawal by Subject |
|
| BG002 | AMG531 (Dose 2) | AMG531: 6 μg/kg, subcutaneous, once weekly |
| BG003 | AMG531 (Dose 4) | AMG531: 10 μg/kg, subcutaneous, once weekly |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline platelet count | Mean | Standard Deviation | cells 10^9/L |
|
| Baseline hemoglobin concentration | There was no data. | Mean | Standard Deviation | g/dL |
|
| Baseline neutrophil count | Mean | Standard Deviation | cells 10^9/L |
|
| OG001 | AMG531 (Dose 2) | AMG531: 3 μg/kg, subcutaneous, once weekly |
| OG002 | AMG531 (Dose 3) | AMG531: 6 μg/kg, subcutaneous, once weekly |
| OG003 | AMG531 (Dose 4) | AMG531: 10 μg/kg, subcutaneous, once weekly |
|
|
| Secondary | Proportion of Subjects Achieving a Platelet Response | The proportion of subjects with a platelet response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104 and Week 1 through Week 156. | All efficacy analyses were carried out using the Per Protocol Set, which was defined as all enrolled subjects who received ≥6 times of the specified dose, with no major violation in the initial dose evaluation period. The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because the Participant Flow module has been recorded based on the Full Analysis Set. | Posted | Count of Participants | Participants | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
|
|
|
| Secondary | Proportion of Subjects Achieving Platelet Transfusion Independency | The proportion of subjects achieving platelet transfusion independency in any time during the initial dose evaluation period , Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated). Platelet transfusion independence is defined as achieving transfusion free period of at least 8 consecutive weeks (56 days). | With respcet to platelet transfusion indendpendence, the proportion will be calculated based on all subjcets in each analysis set and all subjects receving platelet transfusion as a pretreatment 8 weeks prior to the first AMG531 administration respectively. | Posted | Count of Participants | Participants | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
|
|
|
| Secondary | Proportion of Subjects Achieving Erythroid Response and/or Neutrophil Response | The proportion of subjects with erythroid response, neutrophil response and erythroid and/or neutrophil response in any time during the initial dose evaluation period, Week 1 through Week 12, Week 1 through Week 16, Week 1 through Week 24, Week 1 through Week 52, Week 1 through Week 104, and Week1 through Week 156 will be calculated in the same manner as the primary variables (The number of subjects discontinued or subjects who have missing data will not be calculated). | All efficacy analyses were carried out using the Per Protocol Set, which was defined as all enrolled subjects who received ≥6 times of the specified dose, with no major violation in the initial dose evaluation period. The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because the Participant Flow module has been recorded based on the Full Analysis Set. | Posted | Count of Participants | Participants | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
|
|
|
| Secondary | Duration of Platelet Response and Time to Platelet Response | For subjects with a platelet response in any time, time to the initial platelet response and duration of platelet response will be summarized Time to the initial platelet response will be calculated as sampling date (response achieved) minus first dose date of study drug plus 1. Duration of platelet response will be calculated as the maximum of the duration of platelet response for each subject, each duration of response calculated as the date when response is disappeared minus the date when response is achieved. The censoring date is defined as the date of the last Platelet examination or EOS whichever archives first. | A total of 29 subjects achieved a platelet response and the median duration of the platelet response was 77.0 days (range: 5 to 959 days). For the 29 subjects who achieved a platelet response, the median time to the initial platelet response was 43 days (range: 8 to 219 days). | Posted | Median | Full Range | days | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
|
|
|
| Secondary | Proportion of Subjects Achieving Tri-lineage Responses | Tri-lineage response is defined in those achieving platelet response, erythroid response, and neutrophil response all together. The proportion of subjects with tri-lineage response will be calculated in the same manner as the primary variables. Time to tri-lineage response will be summarized in the same manner as time to platelet response. Time to tri-lineage response is defined as duration of the time from Day 1 to the date of platelet response, erythroid response or neutrophil response whichever achieves last in Visit. | All efficacy analyses were carried out using the Per Protocol Set, which was defined as all enrolled subjects who received ≥6 times of the specified dose, with no major violation in the initial dose evaluation period. The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because the Participant Flow module has been recorded based on the Full Analysis Set. | Posted | Count of Participants | Participants | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 157 |
|
|
|
| Secondary | Duration of Study Drug Discontinuation While Maintaining Stable Response | The longest duration of study drug discontinuation in subjects while maintaining a stable response is summarized | 3/33 (9.1%) subjects (who maintained blood cell response) discontinued the study drug during Week 1 to Week 156. | Posted | Median | Full Range | days | Initial dose evaluation period (Week 9), Week 12, Week 16, Week 24, Week 52, Week 104, and Week 156 |
|
|
|
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | AMG531 (Dose 2) | AMG531: Subcutaneous, weekly injection | 1 | 9 | 2 | 9 | 5 | 9 |
| EG002 | AMG531 (Dose 3) | AMG531: Subcutaneous, weekly injection | 0 | 9 | 2 | 9 | 7 | 9 |
| EG003 | AMG531 (Dose 4) | AMG531: Subcutaneous, weekly injection | 0 | 10 | 3 | 10 | 4 | 10 |
| Cataract | Eye disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Macular fibrosis | Eye disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D001855 | Bone Marrow Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| Male |
|
| Week 1 - Week 12 |
|
| Week 1 - Week 16 |
|
| Week 1 - Week 24 |
|
| Week 1 - Week 52 |
|
| Week 1 - Week 104 |
|
| Week 1 - Week 156 |
|
|
| All subjects : Week 1 - Week 12 |
|
|
| All subjects : Week 1 - Week 16 |
|
|
| All subjects : Week 1 - Week 24 |
|
|
| All subjects : Week 1 - Week 52 |
|
|
| All subjects : Week 1 - Week 104 |
|
|
| All subjects : Week 1 - Week 156 |
|
|
| Subjects with TF : Initial dose evaluation period |
|
|
| Subjects with TF : Week 1 - Week 12 |
|
|
| Subjects with TF : Week 1 - Week 16 |
|
|
| Subjects with TF : Week 1 - Week 24 |
|
|
| Subjects with TF : Week 1 - Week 52 |
|
|
| Subjects with TF : Week 1 - Week 104 |
|
|
| Subjects with TF : Week 1 - Week 156 |
|
|
| Erythroid Response : Week 1 - Week 12 |
|
| Erythroid Response : Week 1 - Week 16 |
|
| Erythroid Response : Week 1 - Week 24 |
|
| Erythroid Response : Week 1 - Week 52 |
|
| Erythroid Response : Week 1 - Week 104 |
|
| Erythroid Response : Week 1 - Week 156 |
|
| Neutrophil Response : Initial dose evaluation period |
|
| Neutrophil Response : Week 1 - Week 12 |
|
| Neutrophil Response : Week 1 - Week 16 |
|
| Neutrophil Response : Week 1 - Week 24 |
|
| Neutrophil Response : Week 1 - Week 52 |
|
| Neutrophil Response : Week 1 - Week 104 |
|
| Neutrophil Response : Week 1 - Week 156 |
|
| Erythroid response and/or Neutrophil response : Initial dose evaluation period |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 12 |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 16 |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 24 |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 52 |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 104 |
|
| Erythroid response and/or Neutrophil response : Week 1 - Week 156 |
|
|
| Time to the initial platelet response |
|
|
| Week 13 |
|
| Week 17 |
|
| Week 25 |
|
| Week 27 |
|
| Week 53 |
|
| Week 105 |
|
| Week 157 |
|