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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003395-12 | EudraCT Number |
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Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, participants continued to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the participants discontinued treatment or withdrew from the study.
This Phase 3 study established PK equivalence of ASTX727 to IV decitabine in approximately 227 evaluable participants. Eligible participants were randomized to receive both study treatments: oral investigational drug ASTX727, and IV decitabine, as follows: participants were randomly assigned 1:1 to receive ASTX727 or IV decitabine in Cycle 1 and then cross over to the other therapy in Cycle 2.
In the ASTX727 cycle, participants received the ASTX727 tablet Daily×5. Serial PK measurements (blood draws) were done on Days 1, 2, and 5, along with pre-dose PK assessments on Days 1-5 and an assessment at 3 hours post-dose on Day 3. Participants were required to fast from food for 4 hours on days when receiving ASTX727: at least 2 hours before and 2 hours after dosing.
In the IV decitabine cycle, participants received a 1-hour infusion of IV decitabine 20 mg/m^2 Daily×5. Serial PK measurements were done on Days 1 and 5, along with pre-dose and 1-hour post-infusion assessments on Day 3.
In Cycles ≥3, participants received the ASTX727 tablet Daily×5 in 28-day cycles. (No PK assessments were done from Cycle 3 onward.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | Experimental | Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
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| MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Experimental | Participants with MDS or CMML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
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| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | Experimental | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTX727 | Drug | ASTX727 oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Total 5-day Area Under the Curve From 0 to 24 Hours (AUC0-24) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| MDS/CMML: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. |
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Inclusion Criteria:
Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first 2 treatment cycles.
Men or women ≥18 years who are candidates to receive IV decitabine according to FDA or European Medicines Agency (EMA) approved indications:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate organ function defined as follows:
No major surgery within 30 days of first study treatment.
Life expectancy of at least 3 months.
Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause, defined as no menses for at least 1 year AND either age ≥65 years or follicle-stimulating hormone levels in the menopausal range.
Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method (eg, use of a condom AND diaphragm, with spermicide).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38135371 | Derived | Garcia-Manero G, McCloskey J, Griffiths EA, Yee KWL, Zeidan AM, Al-Kali A, Deeg HJ, Patel PA, Sabloff M, Keating MM, Zhu N, Gabrail NY, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern AE, O'Connell CL, Roboz GJ, Busque L, Buckstein R, Amin H, Randhawa J, Leber B, Shastri A, Dao KH, Oganesian A, Hao Y, Keer HN, Azab M, Savona MR. Oral decitabine-cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study. Lancet Haematol. 2024 Jan;11(1):e15-e26. doi: 10.1016/S2352-3026(23)00338-1. |
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A total of 138 participants with a diagnosis of MDS or CMML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner. A total of 89 participants with a diagnosis of AML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner.
A total of 227 participants took part in the study from 15 February 2018 to 25 May 2023. 138 participants with a diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) took part from the United States and Canada. 89 participants with a diagnosis of acute myeloid leukemia (AML) took part from Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Spain, and United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| 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 | Yes | No | No | Study Protocol | Jan 20, 2021 | Mar 20, 2024 |
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Multicenter, randomized, open-label, 2-period, 2-sequence crossover study
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| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Experimental | Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
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| Dacogen | Drug | Decitabine 20 mg/m^2 one-hour IV infusion |
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| From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years) |
| AML: Number of Participants With Treatment-emergent Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. | From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years) |
| MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs | TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. | From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years) |
| AML: Number of Participants With Grade 3 or Higher TEAEs | TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using CTCAE version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. | From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years) |
| Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation | Summarized data for Cycle 1 and Cycle 2 was reported. | Pre-dose on Day 1 of Cycles 1 and 2 (as Baseline), and Days 8, 15 and 22 of Cycles 1 and 2 (each cycle= 28 days) |
| Total 5-day Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-inf exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-inf (first ASTX727 dose) was added to (Day 2 AUC0-inf+ Day 5 AUC0-inf) × 2. Decitabine 5-day AUC0-inf exposures after IV decitabine were calculated as follows: (Day 1 AUC0-inf+ Day 5 AUC0-inf) / 2 was multiplied by 5. If AUC0-inf on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-inf on Day 5; the converse was also true. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Total 5-day Area Under the Curve From 0 to Last Quantifiable Concentration (AUC0-last) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-last exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-last (first ASTX727 dose) was added to (Day 2 AUC0-last + Day 5 AUC0-last) × 2. Decitabine 5-day AUC0-last exposures after IV decitabine were calculated as follows: (Day 1 AUC0-last + Day 5 AUC0-last) / 2 was multiplied by 5. If AUC0-last on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-last on Day 5; the converse was also true. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Total 5-day Area Under the Curve From 0 to 8 Hours (AUC0-8) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-8 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-8 (first ASTX727 dose) was added to (Day 2 AUC0-8 + Day 5 AUC0-8) × 2. Decitabine 5-day AUC0-8 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-8 + Day 5 AUC0-8) / 2 was multiplied by 5. If AUC0-8 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-8 on Day 5; the converse was also true. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine | AUC0-inf was calculated using the formula AUClast + (Clast / λZ), where Clast is the last quantifiable concentration and λZ is the elimination rate constant. AUC0-inf will be calculated using the linear up-log down method. Summarized data has been reported for cycle 1 and 2. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of Cmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Cmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of Tmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Tmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine | Oral CL/F for oral decitabine was measured only on Day 1 and oral CL/F for oral cedazuridine was measured on Days 1, 2 and 5. Summarized data of Oral CL/F for oral decitabine on Day 1 for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of oral CL/F for oral cedazuridine on Day 1,2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of t1/2 on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of t1/2 on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine | Summarized data of Vz/F on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
| MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria | CR: normal peripheral, persistent granulocyte count ≥1.0x10^9/liter(L), platelet ≥100x10^9/L, Hemoglobin (Hgb) ≥11g/dL, normal bone marrow with persistent marrow blasts ≤5%. mCR: reduction of bone marrow blasts to≤5%, decrease by 50% or more with/without normalization of peripheral counts.PR: normal peripheral counts, granulocyte count ≥1.0x10^9/L, platelet count ≥100x10^9/L, Hgb ≥11 g/dL, normal bone marrow, marrow blasts >5%, reduced by 50% or more for at least 4 weeks. HI: HI-E: Hb increase ≥1.5 g/dL in absence of RBC transfusions. HI-P: Absolute increase of platelet count from <20 to >20X10^9/L by at least 100%,if more than 20x10^9/L, by absolute increase of at least 30x10^9/L in absence of platelet transfusions. HI-N: granulocyte increase ≥100%, by an absolute increase ≥0.5x10^9/L for at least 8 weeks. Percentage of participants with CR, mCR, PR, and HI based on IWG 2003 MDS response criteria are reported. Response has been reported based on participants with MDS or CMML. | Up to approximately 2.7 years |
| AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria | CR was defined as absolute neutrophil content (ANC) ≥1000/ microliter (μL), platelets ≥100,000/μL, independence from red blood cell (RBC) and platelet transfusions over the past week, no leukemic blasts and <5% leukemic blasts. CRp was defined as CR criteria except platelets <100,000/μL.and platelet transfusion over the past week. CRi was defined as CR criteria except ANC <1000/μL or platelets <100,000/μL. Percentage of participants with CR, CRi, CRp, and CR Plus CRp based on IWG 2003 AML response criteria are reported. | Up to approximately 2.4 years |
| AML: Percentage of Participants With CR With Partial Hematologic Recovery (CRh) Based on IWG 2003 AML Response Criteria | CRh was defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/μL and ANC >500/μL), independence from RBC and platelet transfusions within 7 days of bone marrow evaluation, and peripheral blast ≤1%. Percentage of participants with CRh based on IWG 2003 AML response criteria are reported. | Day 1 of Cycle 3 up to approximately 2.4 years (each cycle= 28 days) |
| AML: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria | Time to first response was defined as time in months from the date of first treatment to the first date when any response is achieved. Time to best response was defined in months from the date of first treatment to the first date when a subject's best response, in the order of CR, CRi (or CRp or CRh), or PR, was achieved. Time to CR was defined in months from the date of first treatment to the first date when CR is achieved. CR:ANC ≥1000/ microliter (μL),platelets ≥100,000/μL,independence from RBC and platelet transfusions over the past week, no leukemic blasts, and <5% leukemic blasts.CRp: CR criteria except ANC ≥1000/μL, platelets < 100,000/μL.and platelet transfusion over the past week. CRi:CR criteria except ANC <1000/μL or platelets <100,000/μL.CRh: <5% of blasts in the bone marrow,platelets >50,000/μL and ANC >500/μL, independence from RBC and platelet transfusions within 7 days and peripheral blast ≤1%. PR: CR criteria except decrease of ≥50% in leukemic blasts. | Up to approximately 2.4 years |
| AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria | Duration of CR was defined as the time interval from the first CR to time of relapse. Duration of combined CR and CRh was defined as the time interval from the first CR or CRh to time of relapse. Duration of CR and combined CR and CRh was presented using a Kaplan-Meier estimate. | Up to approximately 2.4 years |
| MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI) | Transfusion independence was defined as no transfusion for 56 consecutive days or more (84 and 112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI). | Up to approximately 2.7 years |
| AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI) | Transfusion independence was defined as no transfusion for 56 consecutive days or more (112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI). | Up to approximately 2.4 years |
| MDS/CMML: Leukemia-free Survival (LFS) | LFS was defined as time from the date of randomization to the date when bone marrow or peripheral blood blasts reach ≥20%, or death from any cause. Participants who hadn't reached AML at the time of the analysis were censored at the date of the last follow-up. Leukemia-free survival was presented using a Kaplan-Meier estimate. | From randomization up to approximately 2.7 years |
| MDS/CMML: Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate. | From randomization up to approximately 2.7 years |
| AML: Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate. | From randomization up to approximately 2.4 years |
| AML: Survival Rates at 6 Months, 1 Year, and 2 Years | One-year survival rate was defined as the survival rate at the end of the first year from the date of randomization. The survival rates at 6 months and at 2 years were calculated similarly. | At Month 6, Year 1 and 2 |
| AML: Event-free Survival (EFS) | EFS was defined as time from the date of randomization to the date of treatment failure [disease progression/relapse (due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse), discontinue treatment due to disease progression or treatment-related AE, or alternative anti-leukemia therapy except for HCT] or death from any cause, whichever occurs first. Participants without documented treatment failure at the time of the analysis were censored at the date of the last follow-up. Event-free survival was presented using a Kaplan-Meier estimate. | From randomization up to approximately 2.4 years |
| AML: Progression-free Survival (PFS) | PFS was defined as time from the date of randomization to the date disease progression due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse) or death from any cause, whichever occurs first. Participants without documented disease progression/relapse or death at the time of the analysis were censored at the date of the last follow-up. Progression-free survival was presented using a Kaplan-Meier estimate. | From randomization up to approximately 2.4 years |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States |
| Compassionate Cancer Care Research Group | Fountain Valley | California | 92708 | United States |
| University of Southern California | Los Angeles | California | 90007 | United States |
| Yale | New Haven | Connecticut | 06510 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Boca Raton Clinical Research | Boca Raton | Florida | 33322 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Mount Sinai | Miami Beach | Florida | 33140 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Regional Cancer Care Associates | Bethesda | Maryland | 20817 | United States |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | United States |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Hackensack | Hackensack | New Jersey | 07601 | United States |
| Roswell Park | Buffalo | New York | 14263 | United States |
| Monter Cancer Center | Lake Success | New York | 11042 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Montefiore | The Bronx | New York | 10467 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Sciences University | Portland | Oregon | 20817 | United States |
| West Penn Allegheny Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Pittsburgh Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Charleston Hematology Oncology Associates | Charleston | South Carolina | 29414 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Baylor Scott & White University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9179 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84124 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Uniklinikum Salzburg | Salzburg | 05020 | Austria |
| General Hospital Hietzing | Vienna | 01130 | Austria |
| Klinikum Wels-Grieskirchen | Wels | 4600 | Austria |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Queen Elizabeth II (QEII) Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Juravinski Hospital & Cancer Center | Hamilton | Ontario | L8V 1C3 | Canada |
| Ottawa Hospital - General Campus | Ottawa | Ontario | K1H8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Center - University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| FN Ostrava | Ostrava | Poruba | 708 00 | Czechia |
| University Hospital Brno | Brno | 62500 | Czechia |
| Fakultni Nemocnice Kralovske Vinohrady FNKV | Prague | Česká Republika | 10034 | Czechia |
| Centre de lutte contre le Cancer Leon Berard | Lyon | Rhone | 69008 | France |
| Hospital Emile Muller | Mulhouse | 68100 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden | 79106 | Germany |
| Philipps-Universität Marburg, Klinik für Innere medizin, Hämatologie, Onkologie und Immunologie | Marburg | Hesse | 35033 | Germany |
| UNIVERSITTSKLINIKUM Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Staedtisches Klinikum Braunschweig | Braunschweig | 38114 | Germany |
| Oberärztin für Innere Medizin, Hämato-/Onkologie und Palliativmedizin | Düsseldorf | 40479 | Germany |
| University Hospital Halle | Halle | 06120 | Germany |
| University of Leipzig | Leisnig | 04103 | Germany |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Somogy Megyei KAposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| University of Pecs, 1st Department of Internal Medicine | Pécs | 7400 | Hungary |
| University of Szeged | Szeged | 6725 | Hungary |
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo | Alessandria | 15121 | Italy |
| AOUC Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS C Granda OM Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliero-Universitaria Maggiore della Carità Novara | Novara | 28100 | Italy |
| Ospedale S. Eugenio | Rome | 00144 | Italy |
| ULSS 8 Vicenza - Ospedale San Bortolo di Vicenza | Vicenza | 36100 | Italy |
| Hospital U. Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18012 | Spain |
| Hospital Duran i Reynals | L'Hospitalet de Llobregat | 08909 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Clinica Universitaria Navarra | Madrid | 28027 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Universitaria Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari I Politècnic La Fe | Valencia | 46026 | Spain |
| Oxford University Hopsitals NHS Trust | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| The Christie NHS Fundation Trust | Manchester | M20 4BX | United Kingdom |
| FG001 | MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Participants with MDS or CMML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| FG002 | AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
| FG003 | AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
| Safety Analysis Set | The Safety Analysis Set included all participants who received any amount of study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants who received any amount of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MDS or CMML: ASTX727 or IV Decitabine | Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| BG001 | AML: ASTX727 or IV Decitabine | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total 5-day Area Under the Curve From 0 to 24 Hours (AUC0-24) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true. | Primary Endpoint Pharmacokinetics (PK) Analysis Set included participants who received full dose of ASTX727 within 3 hours of the intended dosing time, and no vomiting within 6 hours of dosing, and had at least 2 days of evaluable decitabine (AUC0-24) measurements in the ASTX727 cycle, i.e, Day 1 and either Day 2 or Day 5 and received the full IV decitabine dose as a 1-hour infusion. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms per milliliter (h*ng/mL) | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | MDS/CMML: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. | The Safety Analysis Set included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years) |
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| Secondary | AML: Number of Participants With Treatment-emergent Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. | The Safety Analysis Set included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years) |
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| Secondary | MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs | TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. | The Safety Analysis Set included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years) |
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| Secondary | AML: Number of Participants With Grade 3 or Higher TEAEs | TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using CTCAE version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. | The Safety Analysis Set included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years) |
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| Secondary | Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation | Summarized data for Cycle 1 and Cycle 2 was reported. | Pharmacodynamic (PD) LINE-1 Analysis Set included participants who received any amount of study treatment and have LINE-1 methylation data at baseline (Day 1) of Cycle 1 or 2 and on either Day 8 or Day 15 of the respective cycle. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of demethylation | Pre-dose on Day 1 of Cycles 1 and 2 (as Baseline), and Days 8, 15 and 22 of Cycles 1 and 2 (each cycle= 28 days) |
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| Secondary | Total 5-day Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-inf exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-inf (first ASTX727 dose) was added to (Day 2 AUC0-inf+ Day 5 AUC0-inf) × 2. Decitabine 5-day AUC0-inf exposures after IV decitabine were calculated as follows: (Day 1 AUC0-inf+ Day 5 AUC0-inf) / 2 was multiplied by 5. If AUC0-inf on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-inf on Day 5; the converse was also true. | Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and who received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Total 5-day Area Under the Curve From 0 to Last Quantifiable Concentration (AUC0-last) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-last exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-last (first ASTX727 dose) was added to (Day 2 AUC0-last + Day 5 AUC0-last) × 2. Decitabine 5-day AUC0-last exposures after IV decitabine were calculated as follows: (Day 1 AUC0-last + Day 5 AUC0-last) / 2 was multiplied by 5. If AUC0-last on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-last on Day 5; the converse was also true. | Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Total 5-day Area Under the Curve From 0 to 8 Hours (AUC0-8) After Treatment With ASTX727 And IV Decitabine | Total 5-day ASTX727 AUC0-8 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-8 (first ASTX727 dose) was added to (Day 2 AUC0-8 + Day 5 AUC0-8) × 2. Decitabine 5-day AUC0-8 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-8 + Day 5 AUC0-8) / 2 was multiplied by 5. If AUC0-8 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-8 on Day 5; the converse was also true. | Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine | AUC0-inf was calculated using the formula AUClast + (Clast / λZ), where Clast is the last quantifiable concentration and λZ is the elimination rate constant. AUC0-inf will be calculated using the linear up-log down method. Summarized data has been reported for cycle 1 and 2. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per millilitres(ng*h/mL) | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of Cmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Cmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of Tmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Tmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Median | Full Range | hours | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine | Oral CL/F for oral decitabine was measured only on Day 1 and oral CL/F for oral cedazuridine was measured on Days 1, 2 and 5. Summarized data of Oral CL/F for oral decitabine on Day 1 for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of oral CL/F for oral cedazuridine on Day 1,2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litres per hour (L/h) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer | Summarized data of t1/2 on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of t1/2 on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine | Summarized data of Vz/F on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. | Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litres | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days) |
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| Secondary | MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria | CR: normal peripheral, persistent granulocyte count ≥1.0x10^9/liter(L), platelet ≥100x10^9/L, Hemoglobin (Hgb) ≥11g/dL, normal bone marrow with persistent marrow blasts ≤5%. mCR: reduction of bone marrow blasts to≤5%, decrease by 50% or more with/without normalization of peripheral counts.PR: normal peripheral counts, granulocyte count ≥1.0x10^9/L, platelet count ≥100x10^9/L, Hgb ≥11 g/dL, normal bone marrow, marrow blasts >5%, reduced by 50% or more for at least 4 weeks. HI: HI-E: Hb increase ≥1.5 g/dL in absence of RBC transfusions. HI-P: Absolute increase of platelet count from <20 to >20X10^9/L by at least 100%,if more than 20x10^9/L, by absolute increase of at least 30x10^9/L in absence of platelet transfusions. HI-N: granulocyte increase ≥100%, by an absolute increase ≥0.5x10^9/L for at least 8 weeks. Percentage of participants with CR, mCR, PR, and HI based on IWG 2003 MDS response criteria are reported. Response has been reported based on participants with MDS or CMML. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2.7 years |
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| Secondary | AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria | CR was defined as absolute neutrophil content (ANC) ≥1000/ microliter (μL), platelets ≥100,000/μL, independence from red blood cell (RBC) and platelet transfusions over the past week, no leukemic blasts and <5% leukemic blasts. CRp was defined as CR criteria except platelets <100,000/μL.and platelet transfusion over the past week. CRi was defined as CR criteria except ANC <1000/μL or platelets <100,000/μL. Percentage of participants with CR, CRi, CRp, and CR Plus CRp based on IWG 2003 AML response criteria are reported. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2.4 years |
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| Secondary | AML: Percentage of Participants With CR With Partial Hematologic Recovery (CRh) Based on IWG 2003 AML Response Criteria | CRh was defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/μL and ANC >500/μL), independence from RBC and platelet transfusions within 7 days of bone marrow evaluation, and peripheral blast ≤1%. Percentage of participants with CRh based on IWG 2003 AML response criteria are reported. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of Cycle 3 up to approximately 2.4 years (each cycle= 28 days) |
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| Secondary | AML: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria | Time to first response was defined as time in months from the date of first treatment to the first date when any response is achieved. Time to best response was defined in months from the date of first treatment to the first date when a subject's best response, in the order of CR, CRi (or CRp or CRh), or PR, was achieved. Time to CR was defined in months from the date of first treatment to the first date when CR is achieved. CR:ANC ≥1000/ microliter (μL),platelets ≥100,000/μL,independence from RBC and platelet transfusions over the past week, no leukemic blasts, and <5% leukemic blasts.CRp: CR criteria except ANC ≥1000/μL, platelets < 100,000/μL.and platelet transfusion over the past week. CRi:CR criteria except ANC <1000/μL or platelets <100,000/μL.CRh: <5% of blasts in the bone marrow,platelets >50,000/μL and ANC >500/μL, independence from RBC and platelet transfusions within 7 days and peripheral blast ≤1%. PR: CR criteria except decrease of ≥50% in leukemic blasts. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Median | Full Range | months | Up to approximately 2.4 years |
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| Secondary | AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria | Duration of CR was defined as the time interval from the first CR to time of relapse. Duration of combined CR and CRh was defined as the time interval from the first CR or CRh to time of relapse. Duration of CR and combined CR and CRh was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 2.4 years |
|
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| Secondary | MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI) | Transfusion independence was defined as no transfusion for 56 consecutive days or more (84 and 112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI). | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure in specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2.7 years |
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| Secondary | AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI) | Transfusion independence was defined as no transfusion for 56 consecutive days or more (112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI). | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure at specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2.4 years |
|
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| Secondary | MDS/CMML: Leukemia-free Survival (LFS) | LFS was defined as time from the date of randomization to the date when bone marrow or peripheral blood blasts reach ≥20%, or death from any cause. Participants who hadn't reached AML at the time of the analysis were censored at the date of the last follow-up. Leukemia-free survival was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | From randomization up to approximately 2.7 years |
|
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| Secondary | MDS/CMML: Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | From randomization up to approximately 2.7 years |
|
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| Secondary | AML: Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization up to approximately 2.4 years |
|
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| Secondary | AML: Survival Rates at 6 Months, 1 Year, and 2 Years | One-year survival rate was defined as the survival rate at the end of the first year from the date of randomization. The survival rates at 6 months and at 2 years were calculated similarly. | Efficacy Analysis Set included all participants who received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Month 6, Year 1 and 2 |
|
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| Secondary | AML: Event-free Survival (EFS) | EFS was defined as time from the date of randomization to the date of treatment failure [disease progression/relapse (due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse), discontinue treatment due to disease progression or treatment-related AE, or alternative anti-leukemia therapy except for HCT] or death from any cause, whichever occurs first. Participants without documented treatment failure at the time of the analysis were censored at the date of the last follow-up. Event-free survival was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization up to approximately 2.4 years |
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| Secondary | AML: Progression-free Survival (PFS) | PFS was defined as time from the date of randomization to the date disease progression due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse) or death from any cause, whichever occurs first. Participants without documented disease progression/relapse or death at the time of the analysis were censored at the date of the last follow-up. Progression-free survival was presented using a Kaplan-Meier estimate. | Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization up to approximately 2.4 years |
|
MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
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 | MDS or CMML: IV Decitabine | Participants with MDS or CMML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). | 2 | 132 | 24 | 132 | 127 | 132 |
| EG001 | MDS or CMML: ASTX727 | Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. | 56 | 130 | 81 | 130 | 130 | 130 |
| EG002 | MDS or CMML: Not Treated | Participants with MDS or CMML were enrolled in the study but did not receive any study treatment. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | AML: IV Decitabine | Participants with MDS or CMML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycles 1 or 2. | 5 | 78 | 19 | 78 | 70 | 78 |
| EG004 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. | 61 | 80 | 65 | 80 | 76 | 80 |
| EG005 | AML: Not Treated | Participants with AML were enrolled in the study but did not receive any study treatment. | 2 | 2 | 1 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematotoxicity | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pancreatitis Chronic | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Polyserositis | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Peritonsillitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia Fungal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Anorectal Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis Staphylococcal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Clostridium Colitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Enterococcal Bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Klebsiella Bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Liver Abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia Necrotising | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sinusitis Aspergillus | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Exposure To Communicable Disease | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Refractory cytopenia with unilineage dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypersensitivity vasculitis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Extravasation Blood | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Loss Of Personal Independence In Daily Activities | Social circumstances | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Central | Taiho Oncology, Inc. | 609-250-7336 | clinicaltrialinfo@taihooncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan (for MDS and CMML) | Feb 27, 2019 | Mar 20, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan (for AML) | Oct 15, 2021 | Mar 20, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723076 | decitabine and cedazuridine drug combination |
| D000077209 | Decitabine |
| C000633944 | cedazuridine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ≥85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AML: IV Decitabine Versus AML: ASTX727 | Ratio of Geometric LSM | 99.64 | 2-Sided | 90 | 91.23 | 108.8 | Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV). | Equivalence | ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | AML: IV Decitabine | Participants with AML received decitabine 20 mg/m^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| OG002 | AML: IV Decitabine | Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
|
| MDS or CMML: ASTX727 |
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| OG002 | AML: IV Decitabine | Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
|
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| OG002 | AML: IV Decitabine | Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
|
| OG002 | AML: IV Decitabine | Participants with AML received decitabine 20 mg/m^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
| OG002 | AML: IV Decitabine | Participants with AML received decitabine 20 mg/m^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
| OG002 | AML: IV Decitabine | Participants with AML received decitabine 20 mg/m^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
| OG001 |
| AML: ASTX727 |
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
| OG002 | AML: IV Decitabine | Participants with AML received decitabine 20 mg/m^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). |
| OG003 | AML: ASTX727 | Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
|
|
| OG001 | MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Participants with MDS received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| OG002 | CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | Participants with CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
| OG003 | CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | Participants with CMML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study. |
|
|
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 |
Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study. |
|
|
Participants with AML received IV infusion of decitabine 20 mg/m^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
|
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