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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1218-1810 | Registry Identifier | WHO | |
| 2022-501485-22 | Other Identifier | EU CTR |
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| Name | Class |
|---|---|
| Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | INDUSTRY |
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The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luspatercept | Experimental |
| |
| Epoetin alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL | Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase ≥ 1.5 g/dL compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion. | Week 1 through Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks | Red blood cell transfusion independence (RBC-TI) for 24 weeks is defined as the percentage of participants who did not receive RBC transfusions from Week 1 through Week 24. | Week 1 through Week 24 |
| Mean Hemoglobin Change Over 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 107 | Berkeley | California | 94704 | United States | ||
| Local Institution - 115 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41549790 | Derived | Komrokji RS, Hayati S, Ugidos M, Garcia-Manero G, Della Porta MG, Zeidan AM, Santini V, Platzbecker U, Gandhi AK, Suragani RNVS. Impact of Mutational Landscape and Burden on RBC Transfusion Response in Patients With Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the COMMANDS Study. Am J Hematol. 2026 Mar;101(3):427-438. doi: 10.1002/ajh.70171. Epub 2026 Jan 19. | |
| 40377899 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Luspatercept | Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg. |
| FG001 | Epoetin Alfa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
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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 | Mar 31, 2022 |
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| Epoetin alfa | Drug | Specified dose on specified days |
|
|
Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion. |
| Week 1 through Week 24 |
| Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG | The percentage of participants meeting the modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions. | Week 1 through Week 24 |
| Time to Hematologic Improvement - Erythroid Response (HI-E) | Time from first dose to first onset of achieving modified HI-E. The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions. | Week 1 through Week 24 |
| Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 12 Weeks (84 Days) | Percentage of participants who are RBC transfusion-free over a consecutive 84-day period. | Week 1 through Week 24 |
| Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days) | Maximum duration of RBC transfusion independence for participants who achieve RBC-TI ≥ 84 days. | Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks) |
| Time to Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days) | Time from first dose to first onset of transfusion independence ≥ 84 days. | Week 1 through Week 24 |
| Time to First Red Blood Cell (RBC) Transfusion | Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method. | Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks) |
| The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment | RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1. | Week 1 through Week 24 |
| Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 56 Days (8 Weeks) | Defined as percentage of participants achieving RBC-TI for >= 56 days during any consecutive 56-day period from Week 1 through Week 24. | Week 1 through Week 24 |
| Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period | Defined as percentage of participants achieving RBC-TI for >= 168 days during any consecutive 168-day period from Week 1 through Week 48. | Week 1 through Week 48 |
| The Number of Participants With Acute Myeloid Leukemia (AML) Progression | Progression to AML is defined as a diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow. | From randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
| Median Time to Acute Myeloid Leukemia (AML) Progression | Time to AML progression is defined as the time between randomization and first diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow. Participants with diagnosis of AML will be considered to have had an event. Participants who have not progressed to AML at the time of analysis will be censored at the last assessment date which does not indicate progression to AML estimated by Kaplan-Meier method. | From randomization to first diagnosis of AML up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
| Overall Survival (OS) | Time from date of randomization to death due to any cause | Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
| The Number of Participants With Adverse Events (AEs) | Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment. The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death. | From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks) |
| Number of Participants With a Positive Anti-drug Antibody (ADA) Test | Number of participants under each ADA positive category. A participant is counted as 'Treatment-Emergent' if there is a positive post-baseline sample while the baseline sample is ADA negative, or there is a positive post-baseline sample with a titer >= 4-fold of the baseline titer while the baseline sample is ADA positive. A participant is counted as 'Preexisting' if the baseline sample is ADA positive and the participant is not qualified for 'Treatment-Emergent'. If the participant was discontinued from study treatment earlier than one year from the first dose, additional samples will be collected if last ADA is positive. Baseline is defined as the last value on or before the first dose of study drug. | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) | The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug. | Baseline and week 24. |
| Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) | The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:
A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug. | Baseline, Day 1 on weeks 7,13,19, and 24. |
| Area Under the Concentration-time Curve [AUC] | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose |
| Maximum Plasma Concentration of Drug [Cmax] | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose |
| San Diego |
| California |
| 92123 |
| United States |
| Local Institution - 101 | Whittier | California | 90603 | United States |
| Local Institution - 104 | New Haven | Connecticut | 06520 | United States |
| Local Institution - 136 | Washington D.C. | District of Columbia | 20422 | United States |
| Local Institution - 119 | Hudson | Florida | 34667 | United States |
| Local Institution - 120 | St. Petersburg | Florida | 33705 | United States |
| Local Institution - 122 | Tallahassee | Florida | 32308 | United States |
| Local Institution - 108 | Tampa | Florida | 33612 | United States |
| Local Institution - 118 | West Palm Beach | Florida | 33401 | United States |
| Local Institution - 102 | Paducah | Kentucky | 42003 | United States |
| Local Institution - 123 | Bethesda | Maryland | 20817 | United States |
| Local Institution - 117 | Kansas City | Missouri | 64132 | United States |
| Local Institution - 134 | East Brunswick | New Jersey | 08816 | United States |
| Local Institution - 113 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 105 | Greenville | North Carolina | 27858-4354 | United States |
| Local Institution - 131 | Portland | Oregon | 97213 | United States |
| Univ of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 111 | Rock Hill | South Carolina | 29732 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203-1625 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Local Institution - 109 | Houston | Texas | 77030 | United States |
| Local Institution - 114 | Salt Lake City | Utah | 84106 | United States |
| Local Institution - 132 | Charlottesville | Virginia | 22903 | United States |
| Local Institution - 127 | Chesapeake | Virginia | 23320 | United States |
| Local Institution - 206 | Albury | New South Wales | 2640 | Australia |
| Local Institution - 213 | Blacktown | New South Wales | 2148 | Australia |
| Local Institution - 200 | Concord | New South Wales | 2139 | Australia |
| Local Institution - 215 | Kogarah | New South Wales | 2217 | Australia |
| Local Institution - 211 | Nowra | New South Wales | 2541 | Australia |
| Local Institution - 210 | Waratah | New South Wales | 2298 | Australia |
| Local Institution - 207 | Wollongong | New South Wales | 2500 | Australia |
| Local Institution - 208 | Auchenflower | Queensland | 4066 | Australia |
| Local Institution - 202 | Adelaide | South Australia | 5000 | Australia |
| Local Institution - 204 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 203 | Malvern | Victoria | 3144 | Australia |
| Local Institution - 209 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 205 | West Perth | Western Australia | 6005 | Australia |
| Local Institution - 212 | Randwick | 2031 | Australia |
| Local Institution - 442 | Linz | 4020 | Austria |
| Local Institution - 441 | Vienna | 1090 | Austria |
| Local Institution - 475 | Antwerp | 2020 | Belgium |
| Local Institution - 471 | Brasschaat | 2930 | Belgium |
| Local Institution - 474 | Brussels | 1200 | Belgium |
| Local Institution - 472 | Charleroi | 6000 | Belgium |
| Local Institution - 473 | Kortrijk | 8500 | Belgium |
| Local Institution - 470 | Leuven | 3000 | Belgium |
| Local Institution - 476 | Roeselare | 8800 | Belgium |
| Local Institution - 147 | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution - 145 | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution - 142 | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution - 140 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 141 | Toronto | Ontario | M4N 3M5 | Canada |
| Local Institution - 144 | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 148 | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution - 151 | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Local Institution - 152 | Sherbrooke | J1H 5N4 | Canada |
| Local Institution - 560 | Hradec Králové | 500 05 | Czechia |
| Local Institution - 564 | Ostrava-Poruba | 708 52 | Czechia |
| Local Institution - 563 | Prague | 100 34 | Czechia |
| Local Institution - 562 | Prague | 128 08 | Czechia |
| Local Institution - 561 | Prague | 128 20 | Czechia |
| Local Institution - 317 | Angers | 49000 | France |
| Local Institution - 312 | Bayonne | 64109 | France |
| Local Institution - 311 | Caen | 14033 | France |
| Local Institution - 306 | La Tronche | 38700 | France |
| Local Institution - 305 | Le Mans | 72037 | France |
| Local Institution - 309 | Lille | 59037 | France |
| Local Institution - 303 | Limoges | 87042 | France |
| Local Institution - 307 | Nantes | 44093 | France |
| Local Institution - 301 | Nice | 06200 | France |
| Local Institution - 302 | Paris | 75010 | France |
| Local Institution - 313 | Paris | 75014 | France |
| Local Institution - 308 | Pessac | 33604 | France |
| Local Institution - 315 | Pierre-Bénite | 69495 | France |
| Local Institution - 316 | Poitiers | 86021 | France |
| Local Institution - 314 | Strasbourg | 67033 | France |
| Local Institution - 300 | Toulouse | 31059 | France |
| Local Institution - 310 | Tours | 37044 | France |
| Local Institution - 304 | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution - 422 | Baden-Warttemberg | 73557 | Germany |
| Local Institution - 424 | Berlin | 14195 | Germany |
| Local Institution - 428 | Cologne | 50677 | Germany |
| Local Institution - 426 | Dresden | 01307 | Germany |
| Local Institution - 429 | Duisburg | 47166 | Germany |
| Local Institution - 420 | Düsseldorf | 40479 | Germany |
| Local Institution - 431 | Hamburg | 22081 | Germany |
| Local Institution - 435 | Keil | 24105 | Germany |
| Local Institution - 423 | Koblenz | 56068 | Germany |
| Local Institution - 430 | Leipzig | 04103 | Germany |
| Local Institution - 436 | Mannheim | 68167 | Germany |
| Local Institution - 421 | München | 81675 | Germany |
| Local Institution - 425 | Winnenden | 71364 | Germany |
| Local Institution - 427 | Würzburg | 97070 | Germany |
| Local Institution - 389 | Heraklion | Irakleio | 71110 | Greece |
| Local Institution - 396 | Alexandroupoli | 08100 | Greece |
| Local Institution - 397 | Athens | 10676 | Greece |
| Local Institution - 391 | Athens | 115 27 | Greece |
| Local Institution - 395 | Athens | 115 27 | Greece |
| Local Institution - 392 | Athens | 12464 | Greece |
| Local Institution - 398 | Pátrai | 26500 | Greece |
| Local Institution - 393 | Rio Patras | 26500 | Greece |
| Local Institution - 399 | Thessaloniki | 546 36 | Greece |
| Local Institution - 390 | Thessaloniki | 57010 | Greece |
| Local Institution - 535 | Budapest | 1096 | Hungary |
| Local Institution - 534 | Debrecen | 4032 | Hungary |
| Local Institution - 536 | Nyíregyháza | 4400 | Hungary |
| Local Institution - 386 | Haifa | 34362 | Israel |
| Local Institution - 383 | Jerusalem | 9103102 | Israel |
| Local Institution - 384 | Jerusalem | 91120 | Israel |
| Local Institution - 381 | Kfar Saba | 44281 | Israel |
| Local Institution - 385 | Nahariya | 22100 | Israel |
| Local Institution - 382 | Tel Aviv | 64239 | Israel |
| Local Institution - 380 | Ẕerifin | 70300 | Israel |
| Local Institution - 331 | Orbassano | TO | 10043 | Italy |
| Local Institution - 324 | Bologna | 40138 | Italy |
| Local Institution - 327 | Florence | 50134 | Italy |
| Local Institution - 330 | Meldola | 47014 | Italy |
| Local Institution - 321 | Milan | 20162 | Italy |
| Local Institution - 329 | Padova | 35128 | Italy |
| Local Institution - 326 | Reggio Calabria | 89124 | Italy |
| Local Institution - 328 | Roma | 00133 | Italy |
| Local Institution - 332 | Roma | 00189 | Italy |
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| Local Institution - 238 | Matsuyama | Ehime | 790-8524 | Japan |
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| Local Institution - 234 | Fukuoka | 810-8563 | Japan |
| Local Institution - 237 | Hitachi, Ibaraki | 317-0077 | Japan |
| Local Institution - 231 | Kamogawa | 296-8602 | Japan |
| Local Institution - 248 | Kitakyushu-Shi | 806-0034 | Japan |
| Local Institution - 270 | Nagaoka-Shi | 940-2108 | Japan |
| Local Institution - 243 | Nagoya | 460-0001 | Japan |
| Local Institution - 235 | Okayama | 700-8557 | Japan |
| Local Institution - 242 | Osaka | 545-8586 | Japan |
| Local Institution - 241 | Ōgaki | 503-8502 | Japan |
| Local Institution - 233 | Sagamihara | 252-0375 | Japan |
| Local Institution - 246 | Sapporo | 064-0804 | Japan |
| Local Institution - 239 | Sendai | 980-8574 | Japan |
| Local Institution - 232 | Shibuya-ku | 150-8935 | Japan |
| Local Institution - 245 | Shimotsuga-gun | 321-0293 | Japan |
| Local Institution - 230 | Shinagawa-ku, Tokyo | 141-8625 | Japan |
| Local Institution - 540 | Kaunas | LT-50009 | Lithuania |
| Local Institution - 541 | Vilnius | LT-08661 | Lithuania |
| Local Institution - 462 | Amsterdam | 1081 HV | Netherlands |
| Local Institution - 464 | Nijmegen | 6525 GA | Netherlands |
| Local Institution - 460 | Rotterdam | 3015 CE | Netherlands |
| Local Institution - 463 | Sittard-Geleen | 6162 BG | Netherlands |
| Local Institution - 461 | The Hague | 2545 CH | Netherlands |
| Local Institution - 570 | Lodz | Lódzkie | 93-513 | Poland |
| Local Institution - 575 | Gdansk | 80-952 | Poland |
| Local Institution - 572 | Lubin | 20-081 | Poland |
| Local Institution - 576 | Poznan | 60-569 | Poland |
| Local Institution - 573 | Rzwszow | 35-055 | Poland |
| Local Institution - 579 | Słupsk | 76-200 | Poland |
| Local Institution - 578 | Wałbrzych | 58-309 | Poland |
| Local Institution - 577 | Wroclaw | 50-367 | Poland |
| Local Institution - 571 | Wroclaw | 50-556 | Poland |
| Local Institution - 373 | Beja | 7801-849 | Portugal |
| Local Institution - 371 | Braga | 4710-243 | Portugal |
| Local Institution - 372 | Lisbon | 1099-023 | Portugal |
| Local Institution - 370 | Porto | 4200-072 | Portugal |
| Local Institution - 374 | Setúbal | 2910-446 | Portugal |
| Local Institution - 511 | Kaluga | 248007 | Russia |
| Local Institution - 505 | Kirov | 610027 | Russia |
| Local Institution - 509 | Krasnoyarsk | 660022 | Russia |
| Local Institution - 504 | Moscow | 111123 | Russia |
| Local Institution - 507 | Moscow | 123182 | Russia |
| Local Institution - 500 | Moscow | 125284 | Russia |
| Local Institution - 503 | Moscow | 129301 | Russia |
| Local Institution - 510 | Saint Petersburg | 197022 | Russia |
| Local Institution - 506 | Saint Petersburg | 197341 | Russia |
| Local Institution - 508 | Saratov | 410012 | Russia |
| Local Institution - 502 | Tula | 300053 | Russia |
| Local Institution - 251 | Busan | 49241 | South Korea |
| Local Institution - 257 | Daegu | 700-721 | South Korea |
| Local Institution - 250 | Hwasun-Gun | 58128 | South Korea |
| Local Institution - 253 | Seongnam-si | 13620 | South Korea |
| Local Institution - 252 | Seoul | 06351 | South Korea |
| Local Institution - 256 | Seoul | 06591 | South Korea |
| Local Institution - 255 | Seoul | 3080 | South Korea |
| Local Institution - 254 | Seoul | 5505 | South Korea |
| Local Institution - 358 | Barcelona | 08035 | Spain |
| Local Institution - 350 | Barcelona | 08908 | Spain |
| Local Institution - 354 | Granada | 18014 | Spain |
| Local Institution - 352 | Madrid | 28007 | Spain |
| Local Institution - 355 | Madrid | 28041 | Spain |
| Local Institution - 353 | Málaga | 29010 | Spain |
| Local Institution - 361 | Murcia | 30008 | Spain |
| Local Institution - 356 | Ourense | 32005 | Spain |
| Local Institution - 363 | Oviedo | 33011 | Spain |
| Local Institution - 362 | Palma de Mallorca | 7120 | Spain |
| Local Institution - 351 | Salamanca | 37007 | Spain |
| Local Institution - 360 | Seville | 41013 | Spain |
| Local Institution - 357 | Valencia | 46010 | Spain |
| Local Institution - 359 | Valencia | 46026 | Spain |
| Local Institution - 550 | Gothenburg | SE-413 45 | Sweden |
| Local Institution - 552 | Lund | SE-221 85 | Sweden |
| Local Institution - 551 | Stockholm | SE-141 86 | Sweden |
| Local Institution - 450 | Bern | 3010 | Switzerland |
| Local Institution - 452 | Lucerne | 6000 | Switzerland |
| Local Institution - 451 | Winterthur | 8400 | Switzerland |
| Local Institution - 220 | Changhua City, Changhua | 500 | Taiwan |
| Local Institution - 222 | Niaosong District Kaohsiung City | 83301 | Taiwan |
| Local Institution - 223 | Taichung | 40447 | Taiwan |
| Local Institution - 224 | Taichung | 40705 | Taiwan |
| Local Institution - 221 | Taipei | 100225 | Taiwan |
| Local Institution - 342 | Ankara | 06100 | Turkey (Türkiye) |
| Local Institution - 340 | Manisa | 45030 | Turkey (Türkiye) |
| Local Institution - 343 | Trabzon | 61080 | Turkey (Türkiye) |
| Local Institution - 526 | Cherkassy | 18009 | Ukraine |
| Local Institution - 525 | Dnipro | 49102 | Ukraine |
| Local Institution - 522 | Kyiv | 3115 | Ukraine |
| Local Institution - 520 | Lviv | 79044 | Ukraine |
| Local Institution - 523 | Mykolaiv | 54058 | Ukraine |
| Local Institution - 521 | Ternopil | 46002 | Ukraine |
| Local Institution - 401 | Aberdeen | AB25 2ZN | United Kingdom |
| Local Institution - 403 | Bournemouth | BH7 7DW | United Kingdom |
| Local Institution - 405 | Headington, Oxford | OX3 7LE | United Kingdom |
| Local Institution - 407 | Lincoln | LN2 5QY | United Kingdom |
| Local Institution - 404 | London | SE5 9RS | United Kingdom |
| Local Institution - 400 | Manchester | M20 4BX | United Kingdom |
| Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Pozharskaya V, Rose S, Keeperman K, Lai Y, Kalsekar S, Aggarwal B, Miteva D, Valcarcel D, Fenaux P, Shortt J, Della Porta MG, Platzbecker U. Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial. Adv Ther. 2025 Jul;42(7):3576-3589. doi: 10.1007/s12325-025-03208-5. Epub 2025 May 16. |
| 39038479 | Derived | Della Porta MG, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Sep;11(9):e646-e658. doi: 10.1016/S2352-3026(24)00203-5. Epub 2024 Jul 19. |
| 37311468 | Derived | Platzbecker U, Della Porta MG, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Giuseppi AC, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Shetty JK, Hayati S, Vodala S, Prebet T, Degulys A, Paolini S, Cluzeau T, Fenaux P, Garcia-Manero G. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023 Jul 29;402(10399):373-385. doi: 10.1016/S0140-6736(23)00874-7. Epub 2023 Jun 10. |
Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU). |
| COMPLETED | Continuing to Treatment Period |
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| NOT COMPLETED |
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| Treatment |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Luspatercept | Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg. |
| BG001 | Epoetin Alfa | Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL | Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase ≥ 1.5 g/dL compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Number | 95% Confidence Interval | Percent of participants | Week 1 through Week 24 |
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| Secondary | Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks | Red blood cell transfusion independence (RBC-TI) for 24 weeks is defined as the percentage of participants who did not receive RBC transfusions from Week 1 through Week 24. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1 through Week 24 |
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| Secondary | Mean Hemoglobin Change Over 24 Weeks | Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being < 14 days after the previous transfusion. | ITT Population (all randomized participants regardless of whether or not the participant received treatment) with baseline measurements. | Posted | Mean | Standard Deviation | g/dL | Week 1 through Week 24 |
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| Secondary | Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG | The percentage of participants meeting the modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1 through Week 24 |
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| Secondary | Time to Hematologic Improvement - Erythroid Response (HI-E) | Time from first dose to first onset of achieving modified HI-E. The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of >= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of < 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions. | ITT Population (all randomized participants regardless of whether or not the participant received treatment) who achieve HI-E response (Week 1-24) | Posted | Median | Full Range | Days | Week 1 through Week 24 |
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| Secondary | Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 12 Weeks (84 Days) | Percentage of participants who are RBC transfusion-free over a consecutive 84-day period. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Number | 95% Confidence Interval | Percent of participants | Week 1 through Week 24 |
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| Secondary | Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days) | Maximum duration of RBC transfusion independence for participants who achieve RBC-TI ≥ 84 days. | ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI >= 12 Weeks (Week 1-24) responders | Posted | Median | 95% Confidence Interval | Weeks | Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks) |
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| Secondary | Time to Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days) | Time from first dose to first onset of transfusion independence ≥ 84 days. | ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI >= 12 Weeks (Week 1-24) responders | Posted | Median | Full Range | Days | Week 1 through Week 24 |
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| Secondary | Time to First Red Blood Cell (RBC) Transfusion | Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Median | 95% Confidence Interval | Days | Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks) |
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| Secondary | The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment | RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1. | All participants who were randomized and received at least one dose. | Posted | Mean | Standard Deviation | RBC units | Week 1 through Week 24 |
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| Secondary | Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 56 Days (8 Weeks) | Defined as percentage of participants achieving RBC-TI for >= 56 days during any consecutive 56-day period from Week 1 through Week 24. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Number | 95% Confidence Interval | Percent of Participants | Week 1 through Week 24 |
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| Secondary | Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period | Defined as percentage of participants achieving RBC-TI for >= 168 days during any consecutive 168-day period from Week 1 through Week 48. | ITT Population (all randomized participants regardless of whether or not the participant received treatment) whose first dose date is at least 337 days from the cutoff date or discontinued early are included in this analysis. | Posted | Number | 95% Confidence Interval | Percent of participants | Week 1 through Week 48 |
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| Secondary | The Number of Participants With Acute Myeloid Leukemia (AML) Progression | Progression to AML is defined as a diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow. | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Count of Participants | Participants | From randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
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| Secondary | Median Time to Acute Myeloid Leukemia (AML) Progression | Time to AML progression is defined as the time between randomization and first diagnosis of AML as per WHO classification of ≥ 20% blasts in peripheral blood or bone marrow. Participants with diagnosis of AML will be considered to have had an event. Participants who have not progressed to AML at the time of analysis will be censored at the last assessment date which does not indicate progression to AML estimated by Kaplan-Meier method. | ITT Population: all randomized participants regardless of whether or not the participant received treatment | Posted | Median | 95% Confidence Interval | Months | From randomization to first diagnosis of AML up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
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| Secondary | Overall Survival (OS) | Time from date of randomization to death due to any cause | ITT Population - all randomized participants regardless of whether or not the participant received treatment. | Posted | Median | 95% Confidence Interval | Months | Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks) |
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| Secondary | The Number of Participants With Adverse Events (AEs) | Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment. The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death. | Safety Population - all participants who were randomized and received at least one dose of treatment. | Posted | Count of Participants | Participants | From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks) |
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| Secondary | Number of Participants With a Positive Anti-drug Antibody (ADA) Test | Number of participants under each ADA positive category. A participant is counted as 'Treatment-Emergent' if there is a positive post-baseline sample while the baseline sample is ADA negative, or there is a positive post-baseline sample with a titer >= 4-fold of the baseline titer while the baseline sample is ADA positive. A participant is counted as 'Preexisting' if the baseline sample is ADA positive and the participant is not qualified for 'Treatment-Emergent'. If the participant was discontinued from study treatment earlier than one year from the first dose, additional samples will be collected if last ADA is positive. Baseline is defined as the last value on or before the first dose of study drug. | Safety Population (all participants who were randomized and received at least one dose of treatment) with baseline and at least one post-baseline immunogenicity assessment result. - Luspatercept Arm Only. | Posted | Count of Participants | Participants | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose |
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| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) | The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug. | All randomized participants who completed the EORTC QLQ-C30 assessment at baseline and post-baseline assessment at the respective visit. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and week 24. |
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| Secondary | Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) | The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:
A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug. | All randomized participants who completed the Fact-An assessment at baseline and post-baseline assessment at the respective visit. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 1 on weeks 7,13,19, and 24. |
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| Secondary | Area Under the Concentration-time Curve [AUC] | Not Posted | Sep 2027 | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of Drug [Cmax] | Not Posted | Sep 2027 | Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose | Participants |
All-cause mortality was assessed from a participants first dose to primary completion (up to approximately 221 weeks). SAEs and Other AEs were assessed from first dose to 42 days post last dose (up to approximately an average of 72 weeks and a maximum of 208 weeks).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
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 | Luspatercept | Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg. | 39 | 182 | 82 | 182 | 153 | 182 |
| EG001 | Epoetin Alfa | Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU). | 38 | 181 | 71 | 179 | 134 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
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| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | 25.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | 25.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 25.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | 25.1 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | 25.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | 25.1 | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | 25.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | 25.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 25.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | 25.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | 25.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | 25.1 | Systematic Assessment |
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| Coronary artery insufficiency | Cardiac disorders | 25.1 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | 25.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | 25.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | 25.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | 25.1 | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | 25.1 | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | 25.1 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | 25.1 | Systematic Assessment |
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| Macular hole | Eye disorders | 25.1 | Systematic Assessment |
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| Retinal artery occlusion | Eye disorders | 25.1 | Systematic Assessment |
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| Ulcerative keratitis | Eye disorders | 25.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Intestinal haemorrhage | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 25.1 | Systematic Assessment |
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| Asthenia | General disorders | 25.1 | Systematic Assessment |
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| Chest pain | General disorders | 25.1 | Systematic Assessment |
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| Death | General disorders | 25.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | 25.1 | Systematic Assessment |
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| Influenza like illness | General disorders | 25.1 | Systematic Assessment |
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| Malaise | General disorders | 25.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | 25.1 | Systematic Assessment |
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| Pyrexia | General disorders | 25.1 | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | 25.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | 25.1 | Systematic Assessment |
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| Abscess | Infections and infestations | 25.1 | Systematic Assessment |
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| Brain abscess | Infections and infestations | 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | 25.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
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| Candida pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | 25.1 | Systematic Assessment |
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| Chronic hepatitis C | Infections and infestations | 25.1 | Systematic Assessment |
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| Coronavirus pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | 25.1 | Systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | 25.1 | Systematic Assessment |
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| Infection | Infections and infestations | 25.1 | Systematic Assessment |
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| Klebsiella bacteraemia | Infections and infestations | 25.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | 25.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | 25.1 | Systematic Assessment |
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| Pulmonary sepsis | Infections and infestations | 25.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | 25.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | 25.1 | Systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | 25.1 | Systematic Assessment |
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| Tracheobronchitis | Infections and infestations | 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | 25.1 | Systematic Assessment |
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| Acetabulum fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Malignant fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Paraganglion neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Small intestine neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Transformation to acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Meningorrhagia | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Hypertensive nephropathy | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
| |
| Prostatectomy | Surgical and medical procedures | 25.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 25.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Mar 28, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D000740 | Anemia |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000753 | Anemia, Refractory |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621232 | luspatercept |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Protocol Violation |
|
| Study Terminated by Sponsor |
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| Lost to Follow-up |
|
| Withdrawal by Subject |
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| Lack of Efficacy |
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| Disease Progression |
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| Adverse Event |
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| Death |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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