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| ID | Type | Description | Link |
|---|---|---|---|
| I2H-MC-JWYB | Other Identifier | Eli Lilly and Company |
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This study is a multicenter, non-randomized, open-label, Phase 2 study of intravenous LY2090314 in participants with acute leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2090314 | Experimental | Cohort 1: 40 milligrams (mg) LY2090314 administered on Days 1, 8, and 15 of a 28-day cycle for at least two (2) 28-day cycles. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met. Due to a protocol amendment on September 2010, the study added 2 additional treatment schedules/cohorts. Cohort 2: 40 mg dose given on Days 1, 5, and 9 of a 21-day cycle. Cohort 3: 40 mg dose given on Days 1, 5, 9, and 12 of a 21-day cycle. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2090314 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Response of Complete Response or Partial Response | The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/Liter (L) and absolute neutrophil count (ANC) ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. |
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Inclusion Criteria:
Participants must have confirmed diagnosis of one of the following:
Have given written informed consent prior to any study-specific procedures
Have adequate organ function including:
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous approved therapies for acute leukemia, including chemotherapy for at least 14 days, and recovered from the acute effects of therapy. Hydroxyurea used to control peripheral blast count is permitted within the first 2 cycles of treatment on study, but it must be stopped at least 24 hours before study drug administration in Cycle 3
Are reliable and willing to be available for the duration of the study and are willing to follow study procedures
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of greater than or equal to 6 weeks
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | 60637 |
Study had safety lead-in phase [40 milligrams (mg) LY2090314 administered using 3 treatment schedules]. Each cohort of participants had different schedule. Safety lead-in data determined if expansion phase opened to enrollment. No participant enrolled in expansion phase. Participants who completed 2 cycles of treatment considered study completers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1, 40 mg LY2090314: D1, D8, D15 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on Day (D)1, D8, and D15 for two 28-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| FG001 | Cohort 2, 40 mg LY2090314: D1, D5, D9 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| FG002 | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of LY2090314.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, 40 mg LY2090314: D1, D8, D15 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] |
|
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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 | Cohort 1, 40 mg LY2090314: D1, D8, D15 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
An interim data review was performed after 6 participants in the safety lead-in completed 1 cycle of therapy. Based on the interim safety results, the expansion cohort was not opened to enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C584053 | 3-(9-fluoro-2-(piperidin-1-ylcarbonyl)-1,2,3,4-tetrahydro(1,4)diazepino(6,7,1-hi)indol-7-yl)-4-imidazo(1,2-a)pyridin-3-yl-1H-pyrrole-2,5-dione |
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| Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) |
| Percentage of Participants With Best Response of Complete Response or Partial Response | The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/L and ANC ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=[(number of participants with CR or PR)/(number of participants treated)]*100. | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) |
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)] | AUC(0-8) was estimated from the plasma drug concentration time profile. | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] |
| PK: AUC From Time 0 to Infinity [AUC(0-inf)] | AUC(0-inf) was estimated from the plasma drug concentration time profile. | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] |
| PK: Maximum Concentration (Cmax) | Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile. | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] |
| Percent Change From Predose Beta (β)-Catenin Levels | Percent change=[(β-catenin level postdose-predose level)/(predose β-catenin levels)]*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1. | Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started) |
| Number of Participants Who Died | The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported. | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Minneapolis | Minnesota | 55455 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Durham | North Carolina | 27710 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | 77030 | United States |
| Progressive Disease |
|
| Cohort 2, 40 mg LY2090314: D1, D5, D9 |
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| BG002 | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cohort 2, 40 mg LY2090314: D1, D5, D9 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
| OG002 | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. |
|
|
| Secondary | Number of Participants With Best Response of Complete Response or Partial Response | The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/Liter (L) and absolute neutrophil count (ANC) ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. | Participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) |
|
|
|
| Secondary | Percentage of Participants With Best Response of Complete Response or Partial Response | The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/L and ANC ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=[(number of participants with CR or PR)/(number of participants treated)]*100. | Participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)] | AUC(0-8) was estimated from the plasma drug concentration time profile. | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Profiles | Profiles |
|
|
|
| Secondary | PK: AUC From Time 0 to Infinity [AUC(0-inf)] | AUC(0-inf) was estimated from the plasma drug concentration time profile. | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Profiles | Profiles |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) | Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile. | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Profiles | Profiles |
|
|
|
| Secondary | Percent Change From Predose Beta (β)-Catenin Levels | Percent change=[(β-catenin level postdose-predose level)/(predose β-catenin levels)]*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1. | Participants who received at least 1 dose of study drug and had a predose and at least 1 postdose β-catenin sample collected. | Posted | Mean | Standard Deviation | percent change | Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started) |
|
|
|
| Secondary | Number of Participants Who Died | The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported. | Participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] |
|
|
|
| 4 |
| 7 |
| 7 |
| 7 |
| EG001 | Cohort 2, 40 mg LY2090314: D1, D5, D9 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. | 5 | 6 | 6 | 6 |
| EG002 | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. | 6 | 7 | 7 | 7 |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac ventricular disorder | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ileitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Halo vision | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retinal exudates | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gingival blister | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| D007951 | Leukemia, Myeloid |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Cycle 1, Day 1, 4 h postdose |
|
|
| Cycle 1, Day 1, 8 h postdose |
|
|
| Cycle 1, Day 1, 24 h postdose |
|
|
| Cycle 1, Day 5, 2 h postdose |
|
|
| Cycle 1, Day 8, 2 h postdose |
|
|
| Cycle 1, Day 9, 1 h postdose |
|
|
| Cycle 1, Day 9, 2 h postdose |
|
|
| Cycle 1, Day 9, 4 h postdose |
|
|
| Cycle 1, Day 9, 8 h postdose |
|
|
| Cycle 1, Day 9, 24 h postdose |
|
|
| Cycle 1, Day 12, 2 h postdose |
|
|
| Cycle 1, Day 15, 1 h postdose |
|
|
| Cycle 1, Day 15, 2 h postdose |
|
|
| Cycle 1, Day 15, 4 h postdose |
|
|
| Cycle 1, Day 15, 8 h postdose |
|
|
| Cycle 2, Day 1, 2 h postdose |
|
|
| Cycle 3, Day 1, 2 h postdose |
|
|
| Cycle 4, Day 1, 2 h postdose |
|
|
| Cycle 5, Day 1, 2 h postdose |
|
|
| Cycle 6, Day 1, 2 h postdose |
|
|
| Cycle 7, Day 1, 2 h postdose |
|
|
| Cycle 8, Day 1, 2 h postdose |
|
|
| Cycle 9, Day 1, 2 h postdose |
|
|
|
| Death During 30-Day Follow-Up |
|