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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005684-10 | EudraCT Number | EudraCT |
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Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schedule A | Experimental | BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10 |
|
| Schedule B | Experimental | BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 811283 (d 1 and 15) | Drug | BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation". | up to 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria: The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
|
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1247.3.49007 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1247.3.49005 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30450591 | Derived | Dohner H, Muller-Tidow C, Lubbert M, Fiedler W, Kramer A, Westermann J, Bug G, Schlenk RF, Krug U, Goeldner RG, Hilbert J, Taube T, Ottmann OG. A phase I trial investigating the Aurora B kinase inhibitor BI 811283 in combination with cytarabine in patients with acute myeloid leukaemia. Br J Haematol. 2019 May;185(3):583-587. doi: 10.1111/bjh.15563. Epub 2018 Nov 19. No abstract available. |
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68 participants were entered, and 64 were treated with the study treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cytarabine | Drug | Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle |
|
| BI 811283 (d1) | Drug | BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle |
|
| Cytarabine | Drug | Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle |
|
| Data collected up to cut-off date 20Oct2011, Up to 1239 days |
| Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0) | The severity and timing of AEs indicates how well the treatment regimen was tolerated. Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme. | Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days |
| Incidence of Dose Limiting Toxicity (DLT) | Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD) | up to 28 days of treatment |
| Partial Remission | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology. | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| Event Free Survival (EFS) | EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first. | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| Relapse Free Survival | Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first. Number of patients having relapse free survival are presented. | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| Remission Duration | Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause. | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| Overall Survival (OS) | OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause. | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| Cmax (Maximum Measured Concentration of BI 811283 in Plasma) | Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State) | Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State | AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State | AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma) | tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State) | tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1 | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| Cmax (Maximum Measured Concentration of Cytarabine in Plasma) | Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma) | Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| Pharmacodynamic Monitoring | Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes). An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material. | On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only |
| Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone | The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol" -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010). Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated. | -0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours |
| Frankfurt am Main |
| Germany |
| 1247.3.49004 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1247.3.49006 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1247.3.49003 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1247.3.49002 Boehringer Ingelheim Investigational Site | Münster | Germany |
| 1247.3.49001 Boehringer Ingelheim Investigational Site | Ulm | Germany |
| FG001 | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG008 | 80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| FG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| Treated |
|
| Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
68 participants were randomised, and 64 were treated with the study treatment hence the number of participants differs from the number of participants that started in the participant flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG001 | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| BG014 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation". | Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered. | Posted | Number | mg | up to 28 days of treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria: The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
| Treated set | Posted | Number | participants | Data collected up to cut-off date 20Oct2011, Up to 1239 days |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0) | The severity and timing of AEs indicates how well the treatment regimen was tolerated. Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme. | Treated set | Posted | Number | participants | Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Dose Limiting Toxicity (DLT) | Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD) | Treated set | Posted | Number | participants | up to 28 days of treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Partial Remission | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology. | Treated set | Posted | Number | participants | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| |||||||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first. | Treated set | Posted | Mean | Standard Deviation | days | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| ||||||||||||||||||||||||||||||
| Secondary | Relapse Free Survival | Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first. Number of patients having relapse free survival are presented. | Treated set (Only patients with observed cases (OC) values were analysed) | Posted | Number | participants | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| |||||||||||||||||||||||||||||||
| Secondary | Remission Duration | Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause. | Treated set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Deviation | days | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause. | Treated set | Posted | Mean | Standard Deviation | days | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days |
| ||||||||||||||||||||||||||||||
| Secondary | Cmax (Maximum Measured Concentration of BI 811283 in Plasma) | Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1 | Treated set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol·h/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol·h/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State) | Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1 | Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State | AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1 | Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol·h/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State | AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1 | Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol·h/L | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma) | tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Median | Full Range | hours | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State) | tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1 | Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B. | Posted | Median | Full Range | hours | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 |
| ||||||||||||||||||||||||||||||
| Secondary | Cmax (Maximum Measured Concentration of Cytarabine in Plasma) | Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| ||||||||||||||||||||||||||||||
| Secondary | Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma) | Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Median | Full Range | hours | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| ||||||||||||||||||||||||||||||
| Secondary | AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | Treated set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| ||||||||||||||||||||||||||||||
| Secondary | AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283 | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/L | -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine |
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamic Monitoring | Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes). An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material. | Treated set | Posted | On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only |
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone | The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol" -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010). Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated. | Treated set | Posted | -0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours |
|
Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
Not provided
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 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 4 | 4 | 4 | ||
| EG001 | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 2 | 3 | 3 | 3 | ||
| EG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 3 | 3 | 3 | ||
| EG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 4 | 4 | 4 | 4 | ||
| EG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 6 | 7 | 7 | 7 | ||
| EG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 6 | 7 | 7 | 7 | ||
| EG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 4 | 4 | 4 | 4 | ||
| EG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 4 | 4 | 4 | ||
| EG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 5 | 5 | 5 | 5 | ||
| EG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 3 | 3 | 3 | ||
| EG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 7 | 7 | 6 | 7 | ||
| EG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 4 | 4 | 4 | ||
| EG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 3 | 3 | 3 | 3 | ||
| EG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection | 5 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cardiac fibrillation | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Aplasia | Congenital, familial and genetic disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Urostomy complication | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eyelid bleeding | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Palatal disorder | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Salivary gland pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mass | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hepatic vein occlusion | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Infectious disease carrier | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Puncture site infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Drug administration error | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Antithrombin III decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Basophil count increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood cholinesterase decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Mean cell haemoglobin concentration increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Mean cell volume decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Protein total increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Prothrombin time shortened | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| pH urine decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Spinal haematoma | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Catatonia | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Illusion | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemoglobinuria | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bedridden | Social circumstances | MEDDRA 14.1 | Systematic Assessment |
| |
| Catheterisation venous | Surgical and medical procedures | MEDDRA 14.1 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MEDDRA 14.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A |
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
|
|
| 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A |
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120mg (BI 811283+ Cytarabine)- Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 |
| 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A |
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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|
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A |
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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| OG002 | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG003 | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG004 | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG005 | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG006 | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG007 | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG008 | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG009 | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG010 | 240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG011 | 300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG012 | 360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
| OG013 | 420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection); Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle); BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection |
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