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| ID | Type | Description | Link |
|---|---|---|---|
| 184054 | Registry Identifier | JAPIC CTI |
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This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milademetan (90 mg/Day) | Experimental | Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
|
| Milademetan (120 mg/Day) | Experimental | Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
|
| Milademetan (160 mg/Day) | Experimental | Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milademetan | Drug | Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | A dose limiting toxicities (DLTs) is defined as any Grade 3 or higher non-hematological adverse event unless related to the primary disease, course of the primary disease, complications, or concomitant medications, that occurs during the DLT evaluation period (28 days of Cycle 1). The following events will be assessed as DLTs: Grade 4 aspartate aminotransferase (AST)/alanine aminotransferase (ALT), Grade 3 AST/ALT lasting ≥3 days, Grade 3 AST/ALT with Grade ≥2 total bilirubin, and unable to complete at least 75% of the prescribed doses of milademetan in Cycle1 (28 days) as a result of Grade ≥2 events. | First 28 Days of Cycle 1 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs after the first administration, or that worsens relative to the pre-treatment state. An AE is any untoward or unintended sign, symptom, or disease noted in participants who received the study drug, whether it is considered to be related to the study drug or not. | From date of signing of informed consent form up to 30 days after last dose of study drug, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis. | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japanese Red Cross Narita Hospital | Chiba | 286-0041 | Japan | |||
| Kyusyu University Hospital |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 14 participants who met all the inclusion criteria and no exclusion criteria were enrolled in study sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Milademetan (90 mg/Day) | Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| FG001 | Milademetan (120 mg/Day) | Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| FG002 | Milademetan (160 mg/Day) | Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics and baseline characteristics were assessed in the Enrolled Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Milademetan (90 mg/Day) | Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| BG001 | Milademetan (120 mg/Day) | Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | A dose limiting toxicities (DLTs) is defined as any Grade 3 or higher non-hematological adverse event unless related to the primary disease, course of the primary disease, complications, or concomitant medications, that occurs during the DLT evaluation period (28 days of Cycle 1). The following events will be assessed as DLTs: Grade 4 aspartate aminotransferase (AST)/alanine aminotransferase (ALT), Grade 3 AST/ALT lasting ≥3 days, Grade 3 AST/ALT with Grade ≥2 total bilirubin, and unable to complete at least 75% of the prescribed doses of milademetan in Cycle1 (28 days) as a result of Grade ≥2 events. | Dose-limiting toxicities were assessed in the DLT Evaluable Set. 3 participants in the 120-mg cohort were excluded from analysis because study treatment was discontinued before completion of the DLT evaluation period. | Posted | Count of Participants | Participants | First 28 Days of Cycle 1 |
|
Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 1 year.
An AE is any untoward or unintended sign, symptom, or disease noted in participants who received the study drug, whether it is considered to be related to the study drug or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milademetan (90 mg/Day) | Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Daiichi Sankyo, Inc. | 908-992-6400 | CTRinfo@dsi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Jan 18, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
Not provided
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| ID | Term |
|---|---|
| C000717787 | milademetan |
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|
| Time to Reach Maximum Plasma Concentration (Tmax) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis. | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
| Area Under the Plasma Concentration-Time Curve (AUC) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | AUC during 8 hours (AUC8h), AUC during 24 hours (AUC24h), AUC up to the last quantifiable concentration (AUClast), and AUC up to infinity (AUCinf) are presented for Day 1 of Cycle 1 and were assessed using non-compartmental analysis. AUC8h for Day 14 of Cycle 1 is also presented. | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
| Terminal Elimination Half-Life (T1/2) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Terminal elimination half-life (T1/2) was assessed using non-compartmental analysis. | Day 1 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
| Trough Plasma Concentration (Ctrough) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Trough plasma concentration (Ctrough) was assessed using non-compartmental analysis. | Day 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
| Number of Participants With Best Response Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Best response was defined as the best measured response over all response assessments (complete remission [CR], CR with incomplete hematological recovery [CRi], CR with partial hematological recovery [CRh], partial remission [PR], morphologic leukemia-free state [MLFS], stable disease [SD], or progressive disease [PD]) at all time points after the start of study treatment. The best response will be SD if the response is assessed as SD three or more times consecutively in the protocol-specified evaluation of the antitumor effect. If the response is not assessed as SD three or more times consecutively, the best response will be Not Applicable (unconfirmed SD). | From the start of study treatment to the end of study treatment, up to 1 year |
| Fukuoka |
| 812-8582 |
| Japan |
| Gifu Municipal Hospital | Gifu | 500-8513 | Japan |
| Chugoku Central Hospital | Hiroshima | 720-0001 | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | 860-0008 | Japan |
| Tenri Hospital | Nara | 632-8552 | Japan |
| NTT Medical Center Tokyo | Tokyo | 141-8625 | Japan |
| National Hospital Organization Disaster Medical Center | Tokyo | 190-0014 | Japan |
| Withdrawal by Subject |
|
| BG002 | Milademetan (160 mg/Day) | Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Milademetan (90 mg/Day) |
Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| OG001 | Milademetan (120 mg/Day) | Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
| OG002 | Milademetan (160 mg/Day) | Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. |
|
|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs after the first administration, or that worsens relative to the pre-treatment state. An AE is any untoward or unintended sign, symptom, or disease noted in participants who received the study drug, whether it is considered to be related to the study drug or not. | Treatment-emergent adverse events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From date of signing of informed consent form up to 30 days after last dose of study drug, up to 1 year |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis. | Pharmacokinetic parameter was assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis. | Pharmacokinetic parameter was assessed in the Pharmacokinetic Analysis Set. | Posted | Median | Full Range | hours | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | AUC during 8 hours (AUC8h), AUC during 24 hours (AUC24h), AUC up to the last quantifiable concentration (AUClast), and AUC up to infinity (AUCinf) are presented for Day 1 of Cycle 1 and were assessed using non-compartmental analysis. AUC8h for Day 14 of Cycle 1 is also presented. | Pharmacokinetic parameter was assessed in the Pharmacokinetic Analysis Set. 2 participants from the Milademetan 90 mg/day and 160 mg/day cohorts for AUC 24 and AUCinf were excluded from the summary as AUC data was not evaluable. 1 participant from Milademetan 120 mg/day cohort for AUC 24 and AUCinf was excluded from the summary as AUC data was not evaluable. | Posted | Mean | Standard Deviation | ng*h/mL | Days 1 & 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Terminal Elimination Half-Life (T1/2) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Terminal elimination half-life (T1/2) was assessed using non-compartmental analysis. | Pharmacokinetic parameter was assessed in the Pharmacokinetic Analysis Set. 2 participants from the Milademetan 90 mg/day and 160 mg/day cohorts were excluded from the summary as data was not evaluable. 1 participant from Milademetan 120 mg/day cohort was excluded from the summary as data was not evaluable. | Posted | Mean | Standard Deviation | hours | Day 1 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of Milademetan Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Trough plasma concentration (Ctrough) was assessed using non-compartmental analysis. | Pharmacokinetic parameter was assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Day 14 of Cycle 1: Pre-dose and 1, 2, 3, 6, and 8 hours post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Number of Participants With Best Response Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Best response was defined as the best measured response over all response assessments (complete remission [CR], CR with incomplete hematological recovery [CRi], CR with partial hematological recovery [CRh], partial remission [PR], morphologic leukemia-free state [MLFS], stable disease [SD], or progressive disease [PD]) at all time points after the start of study treatment. The best response will be SD if the response is assessed as SD three or more times consecutively in the protocol-specified evaluation of the antitumor effect. If the response is not assessed as SD three or more times consecutively, the best response will be Not Applicable (unconfirmed SD). | Best Response was assessed on the Efficacy Analysis Set. | Posted | Count of Participants | Participants | From the start of study treatment to the end of study treatment, up to 1 year |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | Milademetan (120 mg/Day) | Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. | 0 | 6 | 2 | 6 | 5 | 6 |
| EG002 | Milademetan (160 mg/Day) | Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle. | 0 | 4 | 0 | 4 | 4 | 4 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Skin Infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Zinc deficiency | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Complication of device insertion | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| Cycle 1, Day 14 |
|
|
| Cycle 1, Day 14 |
|
|
| Cycle 1 Day 14: AUC8h |
|
|
| Cycle 1 Day 1: AUC24h |
|
|
| Cycle 1 Day 1: AUClast |
|
|
| Cycle 1 Day 1: AUCinf |
|
|
| CR with incomplete hematological recovery (CRi) |
|
| Partial remission (PR) |
|
| Morphologic leukemia-free state (MLFS) |
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Not applicable (NA) |
|
| Not Evaluable (NE) |
|