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At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.
During the extension phase, participants were treated based on 28-day cycles and monitored for hematologic, nonhematologic, and renal toxicities. Recommended monitoring procedures included complete blood count with differential and platelets at least once each cycle prior to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and additional tests or more frequent monitoring at the investigator's discretion based on the patient's clinical status. The azacitidine dose could be modified for toxicities. Laboratory data were not collected during the extension phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine | Experimental | Azacitidine (study drug) plus best supportive care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period | Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption. | 43- 68 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Melbourne | Victoria | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19230772 | Background | Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21. | |
| 20026804 |
| Label | URL |
|---|---|
| Study record for primary study | View source |
Not provided
Participants were eligible for the extension study of AZA PH GL 2003 CL 001 if they had been randomized to azacitidine treatment in the primary study and receiving azacitidine at the time of study closure, completed 12 months of treatment and observation in the primary study, and signed the informed consent document for the extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azacitidine | Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Herston |
| Australia |
| Perth | Australia |
| Woolloongabba | Australia |
| Plovdiv | Bulgaria |
| Aulnay-sous-Bois | France |
| Berlin | Germany |
| Düsseldorf | Germany |
| Essen | Germany |
| Kiel | Germany |
| Heraklio | Crete | Greece |
| Haidari | Greece |
| Budapest | Hungary |
| Bologna | Italy |
| Florence | Italy |
| Genova | Italy |
| Rome | Italy |
| Nijmegen | Netherlands |
| Lodz | Poland |
| Avda Campanar | Spain |
| León | Spain |
| London | United Kingdom |
| Background |
| Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21. |
| 23585522 | Background | Gore SD, Fenaux P, Santini V, Bennett JM, Silverman LR, Seymour JF, Hellstrom-Lindberg E, Swern AS, Beach CL, List AF. A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial. Haematologica. 2013 Jul;98(7):1067-72. doi: 10.3324/haematol.2012.074831. Epub 2013 Apr 12. |
| 30016552 | Background | Savona MR, Kolibaba K, Conkling P, Kingsley EC, Becerra C, Morris JC, Rifkin RM, Laille E, Kellerman A, Ukrainskyj SM, Dong Q, Skikne BS. Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies. Am J Hematol. 2018 Oct;93(10):1199-1206. doi: 10.1002/ajh.25216. Epub 2018 Sep 3. |
| 20451404 | Background | Seymour JF, Fenaux P, Silverman LR, Mufti GJ, Hellstrom-Lindberg E, Santini V, List AF, Gore SD, Backstrom J, McKenzie D, Beach CL. Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes. Crit Rev Oncol Hematol. 2010 Dec;76(3):218-27. doi: 10.1016/j.critrevonc.2010.04.005. Epub 2010 May 6. |
| 30114559 | Background | Garcia-Manero G, Scott BL, Cogle CR, Boyd TE, Kambhampati S, Hetzer J, Dong Q, Kumar K, Ukrainskyj SM, Beach CL, Skikne BS. CC-486 (oral azacitidine) in patients with myelodysplastic syndromes with pretreatment thrombocytopenia. Leuk Res. 2018 Sep;72:79-85. doi: 10.1016/j.leukres.2018.08.001. Epub 2018 Aug 3. |
| 30037860 | Background | Ma X, Steensma DP, Scott BL, Kiselev P, Sugrue MM, Swern AS. Selection of patients with myelodysplastic syndromes from a large electronic medical records database and a study of the use of disease-modifying therapy in the United States. BMJ Open. 2018 Jul 23;8(7):e019955. doi: 10.1136/bmjopen-2017-019955. |
| 29933073 | Background | de Lima M, Oran B, Champlin RE, Papadopoulos EB, Giralt SA, Scott BL, William BM, Hetzer J, Laille E, Hubbell B, Skikne BS, Craddock C. CC-486 Maintenance after Stem Cell Transplantation in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Biol Blood Marrow Transplant. 2018 Oct;24(10):2017-2024. doi: 10.1016/j.bbmt.2018.06.016. Epub 2018 Jun 20. |
| 30091166 | Background | Wehmeyer J, Zaiss M, Losem C, Schmitz S, Niemeier B, Harde J, Hannig CV, Harich HD, Muller J, Klausmann M, Tessen HW, Potthoff K. Impact of performance status and transfusion dependency on outcome of patients with myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia treated with azacitidine (PIAZA study). Eur J Haematol. 2018 Dec;101(6):766-773. doi: 10.1111/ejh.13160. Epub 2018 Oct 25. |
| 30442503 | Background | Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, Oelschlagel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Groth C, Schubert A, Mende M, Stolzel F, Borkmann C, Kubasch AS, von Bonin M, Serve H, Hanel M, Duhrsen U, Schetelig J, Rollig C, Kramer M, Ehninger G, Bornhauser M, Thiede C. Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol. 2018 Dec;19(12):1668-1679. doi: 10.1016/S1470-2045(18)30580-1. Epub 2018 Nov 12. |
| 30406952 | Background | Boutault R, Peterlin P, Boubaya M, Sockel K, Chevallier P, Garnier A, Guillaume T, Le Bourgeois A, Debord C, Godon C, Le Bris Y, Theisen O, Kroschinsky F, Moreau P, Bene MC, Platzbecker U, Eveillard M. A novel complete blood count-based score to screen for myelodysplastic syndrome in cytopenic patients. Br J Haematol. 2018 Dec;183(5):736-746. doi: 10.1111/bjh.15626. Epub 2018 Nov 8. |
| 30518537 | Background | Wenk C, Garz AK, Grath S, Huberle C, Witham D, Weickert M, Malinverni R, Niggemeyer J, Kyncl M, Hecker J, Pagel C, Mulholland CB, Muller-Thomas C, Leonhardt H, Bassermann F, Oostendorp RAJ, Metzeler KH, Buschbeck M, Gotze KS. Direct modulation of the bone marrow mesenchymal stromal cell compartment by azacitidine enhances healthy hematopoiesis. Blood Adv. 2018 Dec 11;2(23):3447-3461. doi: 10.1182/bloodadvances.2018022053. |
| 30636526 | Background | Zeidan AM, Klink AJ, McGuire M, Feinberg B. Treatment sequence of lenalidomide and hypomethylating agents and the impact on clinical outcomes for patients with myelodysplastic syndromes. Leuk Lymphoma. 2019 Aug;60(8):2050-2055. doi: 10.1080/10428194.2018.1551538. Epub 2019 Jan 14. |
| 30584089 | Background | Leung KK, Nguyen A, Shi T, Tang L, Ni X, Escoubet L, MacBeth KJ, DiMartino J, Wells JA. Multiomics of azacitidine-treated AML cells reveals variable and convergent targets that remodel the cell-surface proteome. Proc Natl Acad Sci U S A. 2019 Jan 8;116(2):695-700. doi: 10.1073/pnas.1813666116. Epub 2018 Dec 24. |
| 30653424 | Background | Craddock C, Slade D, De Santo C, Wheat R, Ferguson P, Hodgkinson A, Brock K, Cavenagh J, Ingram W, Dennis M, Malladi R, Siddique S, Mussai F, Yap C. Combination Lenalidomide and Azacitidine: A Novel Salvage Therapy in Patients Who Relapse After Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia. J Clin Oncol. 2019 Mar 1;37(7):580-588. doi: 10.1200/JCO.18.00889. Epub 2019 Jan 17. |
| 21656747 | Result | Silverman LR, Fenaux P, Mufti GJ, Santini V, Hellstrom-Lindberg E, Gattermann N, Sanz G, List AF, Gore SD, Seymour JF. Continued azacitidine therapy beyond time of first response improves quality of response in patients with higher-risk myelodysplastic syndromes. Cancer. 2011 Jun 15;117(12):2697-702. doi: 10.1002/cncr.25774. Epub 2011 Jan 10. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azacitidine | Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day. |
| 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 | participants |
| |||||||||||||||||||||||
| French-American-British (FAB) Classification | FAB classifications were determined by the Independent Review Committee | Number | participants |
| ||||||||||||||||||||||
| World Health Organization (WHO) Classification | WHO classifications were determined by the Independent Review Committee. | Number | participants |
| ||||||||||||||||||||||
| International Prognostic Scoring System (IPSS) | The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The scale is 0-3.5 at .5 increments. Scores of 2.5-3.5 represent high risk which corresponds to poorer prognosis. The assessment was performed by the Independent Review Committee. | Number | participants |
|
| 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 | Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period | Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption. | Safety population includes all 40 participants in the extension study. | Posted | Number | participants | 43- 68 months |
|
|
|
Extension study covering 43- 68 months
Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azacitidine | Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day. | 20 | 40 | 36 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| White blood cell count increase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiovascular insufficiency | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ecchmyosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CL Beach | Celgene Corporation | CLBeach@celgene.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Modified chronic myelomonocytic leukemia |
|
| Acute myeloid leukemia |
|
| Myeloproliferative disease |
|
| Chronic myelomonocytic leukemia - 1 (CMMoL-1) |
|
| Chronic myelomonocytic leukemia - 2 (CMMoL-2) |
|
| Acute myeloid leukemia |
|
|
| High risk (2.5-3.5) |
|
| Not applicable |
|
| Indeterminate |
|
| Title | Measurements |
|---|---|
|
| Participants with >=1 serious trtment related TEAE |
|
| Participants w TEAE leading to discontinued treat |
|
| Participants w TEAE leading to dose reduction |
|
| Participants w TEAE leading to dose interruption |
|