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This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Romiplostim (formerly AMG 531) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim (formerly AMG 531) | Drug | Subjects will begin the study at an initial dose of 750 µg. Except for:
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Summary of Adverse Events | During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks . | |
| Incidence of Antibody (AB) Formation | During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Bleeding Events Per 100 Subject Years | During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28616874 | Derived | Fenaux P, Muus P, Kantarjian H, Lyons RM, Larson RA, Sekeres MA, Becker PS, Orejudos A, Franklin J. Romiplostim monotherapy in thrombocytopenic patients with myelodysplastic syndromes: long-term safety and efficacy. Br J Haematol. 2017 Sep;178(6):906-913. doi: 10.1111/bjh.14792. Epub 2017 Jun 14. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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This study was available to subjects who completed a previous romiplostim study for the treatment of thrombocytopenia in subjects with low or intermediate-1 risk MDS. First Subject Enrolled: 17-Jul-2007; Last Subject Enrolled: 15-Feb-2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Romiplostim | Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| During the treatment period. The average duration of romiplostim exposure is 56 weeks. |
| Platelet Transfusion Events Per 100 Subject Years | During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events. | During the treatment period. The average duration of romiplostim exposure is 56 weeks. |
| Weeks With Platelet Response Per Year | During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | During the treatment period. The average duration of romiplostim exposure is 56 weeks. |
| Time to First Platelet Response | Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | During treatment period. The average duration of romiplostim exposure is 56 weeks. |
| Duration of Platelet Response | Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | During treatment period. The average duration of romiplostim exposure is 56 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Romiplostim | Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participant |
| |||||||||||||||||||||||
| Myelodysplastic Syndromes World Health Organization Classification at Study Screening | Number | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology (ECOG) performance status | Number | Participants |
| |||||||||||||||||||||||
| Baseline Platelet Count | Mean | Standard Deviation | 10^9/L |
|
| 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 | Overall Summary of Adverse Events | Safety analysis includes subjects who took at least one dose of romiplostim. | Posted | Dec 2012 | Number | Participant | During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks . |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Weekly Bleeding Events Per 100 Subject Years | During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day. | Safety analysis includes subjects who received at least one dose of romiplostim. | Posted | Dec 2012 | Mean | 95% Confidence Interval | Events/100 subject-year | During the treatment period. The average duration of romiplostim exposure is 56 weeks. | Events | Events |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Platelet Transfusion Events Per 100 Subject Years | During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events. | Safety analysis includes subjects who received at least one dose of romiplostim. | Posted | Dec 2012 | Mean | 95% Confidence Interval | Events/100 subject-year | During the treatment period. The average duration of romiplostim exposure is 56 weeks. | Events | Events |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Weeks With Platelet Response Per Year | During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | Safety analysis includes subjects who received at least one dose of romiplostim. | Posted | Dec 2012 | Mean | 95% Confidence Interval | Weeks/Subject-year | During the treatment period. The average duration of romiplostim exposure is 56 weeks. | Weeks with Platelet Response | Weeks with Platelet Response |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Platelet Response | Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | Safety analysis includes subjects who received at least one dose of romiplostim. | Posted | Dec 2012 | Median | 95% Confidence Interval | Weeks | During treatment period. The average duration of romiplostim exposure is 56 weeks. | Weeks with Platelet Response | Weeks with Platelet Response |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Platelet Response | Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L. | Safety analysis includes subjects who received at least one dose of romiplostim. | Posted | Dec 2012 | Median | Full Range | Weeks | During treatment period. The average duration of romiplostim exposure is 56 weeks. | Weeks with Platelet Response | Weeks with Platelet Response |
|
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Antibody (AB) Formation | Safety analysis includes subjects who took at least one dose of romiplostim. | Posted | Dec 2012 | Number | Participant | During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks. |
|
|
The average duration is 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Romiplostim | 29 | 72 | 66 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscular dystrophy | Congenital, familial and genetic disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary hilum mass | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary vascular disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
Early termination leading to small number of subjects analyzed;
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial resul
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C488777 | romiplostim |
Not provided
Not provided
Not provided
| Hispanic or Latino |
|
| Other |
|
| RAEB-1: Refractory Anemia with Excess Blasts-1 |
|
| RAEB-2: Refractory Anemia with Excess Blasts-2 |
|
| RCMD:Refractory cytopenia w multilineage dysplasia |
|
| RCMD-RS: RCMD and ringed sideroblasts |
|
| MDS-U: Myelodysplastic syndrome - unclassified |
|
| MDS associated with isolated del(5q) |
|
| 2: Capable of selfcare but unable to work |
|
| >=3: Capable of only limited selfcare or worse |
|
| Title | Measurements |
|---|---|
|
| Subjects Reporting Any Serious AE |
|
| Subjects Withdrew Study or Stop IP Due to AE |
|
| Events |
|
|
| Events |
|
|
| Weeks with Platelet Response |
|
|
| Weeks with Platelet Response |
|
|
| Weeks with Platelet Response |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Positive binding AB to IP at or before baseline |
| |||||
| Neutralizing AB to IP at or before baseline |
| |||||
| Binding AB positive to IP post-baseline only |
| |||||
| Persistent binding AB positive to IP |
| |||||
| Transient binding AB positive to IP |
| |||||
| Positive binding AB to TPO at or before baseline |
| |||||
| Neutralizing AB to TPO at or before baseline |
| |||||
| Binding AB positive to TPO post-baseline only |
| |||||
| Persistent binding AB positive to TPO |
| |||||
| Transient binding AB positive to TPO |
|