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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3543-004 | Other Identifier | MSD | |
| IMG-7289-CTP-203 | Other Identifier | Imagobio ID | |
| 2022-002262-32 | EudraCT Number |
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This study will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat, in participants with polycythemia vera (PV). At Week 36 of dosing, participants will be assessed for eligibility to receive additional treatment through Week 52. Participants deriving clinical benefit and safely tolerating bomedemstat will qualify for continued treatment at the Investigator's discretion.
With Amendment 3, after all ongoing participants have reached 52 weeks of treatment, eligible participants may transition to a bomedemstat extension study if available. With Amendment 4, all secondary PK and participant reported outcome measures were designated as exploratory.
Per protocol, participants who derived clinical benefit (no progressive disease) and safely tolerated drug may have qualified for enrollment into the bomedemstat extension study (NCT06351631).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bomedemstat | Experimental | Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bomedemstat | Drug | Oral capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported. | Up to approximately 52 weeks |
| Number of Participants Who Discontinued Study Intervention Due to AEs | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention due to an AE are reported. | Up to approximately 52 weeks |
| Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36 | Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to <45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to <45% without concomitant phlebotomy at Week 36 are reported. | Up to approximately 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy | Total response duration was defined as the summation of all Hct <45% response durations, where an individual response duration starts at the timepoint where the Hct <45% and ends at the first subsequent occurrence of phlebotomy or Hct >=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to <45% without phlebotomy was presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BRCR Global ( Site 0120) | Plantation | Florida | 33322 | United States | ||
| Hematology Oncology of the North Shore ( Site 0104) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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This study recruited participants with Polycythemia Vera (PV) requiring cytoreduction that have failed at least one standard cytoreductive therapy (failure is the equivalent of resistance or intolerance).
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| ID | Title | Description |
|---|---|---|
| FG000 | Bomedemstat | Participants received 40 mg bomedemstat orally once daily for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 29, 2024 |
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| Up to approximately 22 months |
| Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36 | Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10^9/L must achieve an additional on-study platelet count ≤450 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10^9/L by week 36 are reported. | Up to approximately 36 weeks |
| Duration of Platelet Count ≤ 450 x 10^9/L | Total response duration was defined as the summation of all platelet ≤450 x 10^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10^9/L and ends at the first subsequent occurrence of platelet >450 x 10^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10^9/L in participants are reported. | Up to approximately 22 months |
| Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36 | WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts <10 X 10^9/L must achieve an additional on-study WBC count <10 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count <10 X 10^9/L week 36 are reported. | Up to approximately 36 weeks |
| Duration of White Blood Cell (WBC) Count <10 x 10^9/L | Total response duration was defined as the summation of all WBC <10 x 10^9/L response durations, where an individual response duration starts at the timepoint when WBC <10 x 10^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count <10 X 10^9/L in participants are reported. | Up to approximately 22 months |
| Number of Participants With Thrombotic Events | Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying polycythemia vera (PV); other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported. | Up to approximately 22 months |
| Number of Participants With Major Hemorrhagic Events | Hemorrhagic events were defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported. | Up to approximately 22 months |
| Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks | Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography [CT] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume >450 cm^3) who achieved any reduction in spleen volume by Week 36 are reported. | Up to approximately 36 weeks |
| Number of Participants With Progressive Disease (PD) | PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported. | Up to approximately 52 weeks |
| Skokie |
| Illinois |
| 60076-1264 |
| United States |
| University of Michigan Comprehensive Cancer Center ( Site 0008) | Ann Arbor | Michigan | 48109 | United States |
| Comprehensive Cancer Centers of Nevada - Peak ( Site 0118) | Las Vegas | Nevada | 89128 | United States |
| Duke University Medical Center ( Site 0016) | Durham | North Carolina | 27705 | United States |
| Ohio State University Comprehensive Cancer Center ( Site 0103) | Columbus | Ohio | 43203 | United States |
| OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102) | Portland | Oregon | 97239-4503 | United States |
| Huntsman Cancer Hospital at the University of Utah ( Site 0119) | Salt Lake City | Utah | 84112 | United States |
| Sunshine Coast Hematology and Oncology Clinic (Site 0506) | Sunshine Coast | Queensland | 4556 | Australia |
| Monash Medical Centre ( Site 0006) | Clayton | Victoria | 3168 | Australia |
| Royal Perth Hospital ( Site 0504) | Perth | Western Australia | 6000 | Australia |
| Gloucestershire Royal Hospital ( Site 0205) | Gloucester | England | GL1 3NN | United Kingdom |
| United Lincolnshire Hospitals NHS Trust ( Site 0204) | Lincoln | Great Britain | LN2 5QY | United Kingdom |
| Imperial College London ( Site 0025) | London | Great Britain | W12 0HS | United Kingdom |
| Boston Pilgrim Hospital ( Site 0207) | Boston | Lincolnshire | PE21 9QS | United Kingdom |
| Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020) | London | London, City of | SE1 9RT | United Kingdom |
| Royal Gwent Hospital ( Site 0201) | Newport | Wales | NP9 2UB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bomedemstat | Participants received 40 mg bomedemstat orally once daily for 52 weeks. |
| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Mean Hematocrit Counts at Baseline | Hematocrit also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells relative to total blood volume. Baseline hematocrit levels were assessed from blood samples using a hematology analyzer or microcapillary, and the mean calculated. | Mean | Standard Deviation | Percentage |
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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 | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported. | All participants who received at least one dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 52 weeks |
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| ||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Intervention Due to AEs | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention due to an AE are reported. | All participants who received at least one dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 52 weeks |
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| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36 | Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to <45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to <45% without concomitant phlebotomy at Week 36 are reported. | All participants who received at least one dose of study intervention and had a valid baseline and one valid post-baseline hematology measure | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 36 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy | Total response duration was defined as the summation of all Hct <45% response durations, where an individual response duration starts at the timepoint where the Hct <45% and ends at the first subsequent occurrence of phlebotomy or Hct >=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to <45% without phlebotomy was presented. | All participants who received at least one dose of study intervention and had a sustained reduction of Hct to <45% at any timepoint | Posted | Median | Full Range | Months | Up to approximately 22 months |
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| Secondary | Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36 | Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10^9/L must achieve an additional on-study platelet count ≤450 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10^9/L by week 36 are reported. | All participants who received at least one dose of study intervention and had a valid baseline and one valid post-baseline hematology measure | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 36 weeks |
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| Secondary | Duration of Platelet Count ≤ 450 x 10^9/L | Total response duration was defined as the summation of all platelet ≤450 x 10^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10^9/L and ends at the first subsequent occurrence of platelet >450 x 10^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10^9/L in participants are reported. | All participants who received at least one dose of study intervention and had platelet count ≤ 450 x 10^9/L at any timepoint | Posted | Median | Full Range | Months | Up to approximately 22 months |
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| Secondary | Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36 | WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts <10 X 10^9/L must achieve an additional on-study WBC count <10 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count <10 X 10^9/L week 36 are reported. | All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 36 weeks |
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| Secondary | Duration of White Blood Cell (WBC) Count <10 x 10^9/L | Total response duration was defined as the summation of all WBC <10 x 10^9/L response durations, where an individual response duration starts at the timepoint when WBC <10 x 10^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count <10 X 10^9/L in participants are reported. | All participants who received at least one dose of study intervention and had WBC count <10 x 10^9/L at any timepoint | Posted | Median | Full Range | Months | Up to approximately 22 months |
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| Secondary | Number of Participants With Thrombotic Events | Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying polycythemia vera (PV); other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported. | All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure | Posted | Count of Participants | Participants | Up to approximately 22 months |
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| Secondary | Number of Participants With Major Hemorrhagic Events | Hemorrhagic events were defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported. | All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure | Posted | Count of Participants | Participants | Up to approximately 22 months |
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| Secondary | Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks | Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography [CT] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume >450 cm^3) who achieved any reduction in spleen volume by Week 36 are reported. | All participants who received at least one dose of study intervention and had an enlarged spleen of >450 cm^3 at baseline and had a valid baseline and post-baseline measurement | Posted | Count of Participants | Participants | Up to approximately 36 weeks |
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| Secondary | Number of Participants With Progressive Disease (PD) | PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported. | All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure | Posted | Count of Participants | Participants | Up to approximately 52 weeks |
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Up to approximately 22 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
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 | Bomedemstat | Participants received 40 mg bomedemstat orally once daily for 52 weeks. | 1 | 20 | 8 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Osteomyelitis acute | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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Sponsor will actively pursue publication of the results of the study in cooperation with the Lead Investigators subject to the terms and conditions of the clinical trial agreement between Sponsor and Investigators. The Lead/Coordinating Investigator, with the agreement of Sponsor, will coordinate the principal publication of the data arising from the study. Participant names and other personal data may not be disclosed in any publication without prior written authorization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Mar 17, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730033 | bomedemstat |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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