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Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse may be eligible for this trial. The trial will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI836858 10milligram(mg)(Patients with relapsed\refractoryAML) | Experimental | Patients with relapsed\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
|
| BI 836858 20 mg (Patients with relapsed\refractory AML) | Experimental | Patients with relapsed\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
|
| BI 836858 40 mg (Patients with relapsed\refractory AML) | Experimental | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
|
| BI 836858 40 mg (Patients with AML in CR) | Experimental | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 836858 | Drug | Monotherapy with BI 836858 administered as intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the Maximum Tolerated Dose (MTD) of BI 836858 | This trial was discontinued prior to reaching the primary endpoint of determining MTD. | From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days. |
| Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation | Dose limiting toxicity was defined as any non-disease-related, non-hematological Adverse Events (AE) of Common Terminology Criteria for AE (CTCAE) grade 3 or higher. Number of patients with DLT during the MTD evaluation period for evaluation for patients with refractory or relapsed acute myeloid leukemia, the first 2 cycles (i.e. patient received at least 4 administrations of BI 836858 and reached end of Cycle 2) and for AML patients in CR with high risk to relapse, the first 2 cycles (i.e. patient has received at least 2 administrations of BI 836858 and reached end of Cycle 2). | From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD) | BOR for patients with refractory/relapsed acute myeloid leukemia defined as: -CR:Morphologically leukemia free state/absolute neutrophil count≥1000/microliter(μL)and platelets≥100,000/μL. No transfusion for 1week prior to assessment -CRi:Met criteria for CR, except absolute neutrophils<1000/μl/platelets<100,000/μl -PR:Met criteria for CR, except leukemic blasts in bone marrow may range from 5 to 25% as long as count has decreased by at least 50% from pre-study treatment, or<5% blasts in presence of Auer rods or abnormal morphology -TF:Patient survives≥7 days following completion of initial 2 treatment cycles with persistent leukemia in the last peripheral blood smear or bone marrow or with persistent extramedullary disease - PD:Patient survives>7 days following completion of initial 2 treatment cycles with increase of blast population in bone marrow or peripheral blood by>50% or aggravation or new development of extramedullary disease or further deterioration or death due to leukemia |
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Inclusion criteria:
Exclusion criteria:
Patients with acute promyelocytic leukemia according to WHO definition.
Patients with refractory or relapsed acute myeloid leukemia > 5.000 blasts in the peripheral blood.
Anti-leukemia therapy within two weeks before first treatment with BI 836858, 4 weeks for biologics. Parallel treatment with Hydroxyurea ia allowed with refractory or relapsed acute myeloid leukemia patients.
Allogeneic stem cell transplantation within the last 28 days before first treatment with graft versus host disease requiring more than 20 mg of steroids per day. Steroid dosage must be stable within two weeks prior to start of treatment.
Patients who are candidates for allogeneic stem cell transplantation (for patients with refractory or relapsed acute myeloid leukemia).
Second malignancy currently requiring active therapy.
Symptomatic central nervous system involvement
Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN for those with Gilbert syndrome.
Prothrombin time (PT) >1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.
Serum creatinine greater than 2.0 mg/dl
Known human immunodeficiency virus (HIV) infection or active hepatitis B virus or hepatitis C virus infection.
Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with trial requirements
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for 6 months after the last administration of BI 836858
Pregnant or nursing female patients
Treatment with another investigational agent under the following conditions:
Prior treatment with a CD33 antibody
Patient unable or unwilling to comply with the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Johns Hopkins Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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This study initially enrolled patients diagnosed with refractory or relapsed AML who had failed at least 1 prior line of therapy and was later amended to include patients with AML who were in CR with a high risk to relapse.
Phase1, open-label, non-randomized, dose-escalation, 3+3 design study followed by expansion cohort with two separate patient populations:1) patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) who have failed at least one prior line of therapy(2) patients with AML who are in complete remission (CR) with high risk to relapse.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML) | Patients with relapsed\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| FG001 | BI 836858 20 mg (Patients With Relapsed\Refractory AML) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2016 | Jan 11, 2024 |
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| From first administration of study drug until the earliest of progressive disease (PD), death or last adequate disease assessment before new anti-cancer therapy, up to 299 days. |
| Progression Free Survival for Patients With Refractory or Relapsed Acute Myeloid Leukemia | Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death. | From first administration of study drug until progressed according to disease assessment, relapse, or death without progression, up to 167 days. |
| Time to Treatment Failure for Patients With Refractory or Relapsed Acute Myeloid Leukemia | Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy. | From first administration of study drug until progressive disease, relapse, death or start of next anti-AML therapy, up to 167 days. |
| Progression Free Survival for AML Patients in CR With High Risk to Relapse | Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death for AML patients in CR with high risk to relapse. | From first treatment with study drug until disease progression, relapse or death for AML patients in CR with high risk to relapse, up to 409 days. |
| Time to Treatment Failure for AML Patients in CR With High Risk to Relapse | Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy. | From first treatment with study drug until disease progression, relapse, death or start of next AML therapy for AML patients in CR with high risk to relapse, up to 409 days. |
| Maximum Measured Plasma Concentration (Cmax) | Maximum measured plasma concentration (Cmax) after the first infusion is presented. | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion. |
| Time From Dosing to the Maximum Plasma Concentration (Tmax) | Time from dosing to the maximum plasma concentration (tmax) after the first infusion is presented. | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval of One Week (AUC0-168) | Area under the plasma concentration-time curve over the time interval of one week (AUC0-168) after the first infusion is presented. | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after BI 836858 infusion. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval of One Treatment Cycle (AUC0-tz) | Area under the plasma concentration-time curve over the time interval of one treatment cycle (AUC0-tz) is presented. One treatment cycle included a first and a second infusion. | At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-infinity) | Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-infinity) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Terminal Half-life (t1/2) | Terminal half-life (t1/2) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Mean Residence Time After Intravenous Infusion (MRT) | Mean residence time after intravenous infusion (MRT) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Total Plasma Clearance (CL) | Total plasma clearance (CL) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Apparent Volume of Distribution During the Terminal Phase (Vz) | Apparent volume of distribution during the terminal phase (Vz) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Volume of Distribution After Intravenous Infusion at Steady State (Vss) | Volume of distribution after intravenous infusion at steady state (Vss) is presented. | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable data point (AUC0-tz) is presented. | At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion. |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
Patients with relapsed\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| FG002 | BI 836858 40 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| FG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
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| NOT COMPLETED |
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Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML) | Patients with relapsed\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| BG001 | BI 836858 20 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| BG002 | BI 836858 40 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| BG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Determination of the Maximum Tolerated Dose (MTD) of BI 836858 | This trial was discontinued prior to reaching the primary endpoint of determining MTD. | MTD evaluable set (non-replaced patients) defined as patients who completed the first two treatment cycles. | Posted | Number | Milligram (mg) | From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days. |
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| Primary | Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation | Dose limiting toxicity was defined as any non-disease-related, non-hematological Adverse Events (AE) of Common Terminology Criteria for AE (CTCAE) grade 3 or higher. Number of patients with DLT during the MTD evaluation period for evaluation for patients with refractory or relapsed acute myeloid leukemia, the first 2 cycles (i.e. patient received at least 4 administrations of BI 836858 and reached end of Cycle 2) and for AML patients in CR with high risk to relapse, the first 2 cycles (i.e. patient has received at least 2 administrations of BI 836858 and reached end of Cycle 2). | MTD evaluable set (non-replaced patients) defined as patients who completed the first two treatment cycles. | Posted | Count of Participants | Participants | From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days. |
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| Secondary | Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD) | BOR for patients with refractory/relapsed acute myeloid leukemia defined as: -CR:Morphologically leukemia free state/absolute neutrophil count≥1000/microliter(μL)and platelets≥100,000/μL. No transfusion for 1week prior to assessment -CRi:Met criteria for CR, except absolute neutrophils<1000/μl/platelets<100,000/μl -PR:Met criteria for CR, except leukemic blasts in bone marrow may range from 5 to 25% as long as count has decreased by at least 50% from pre-study treatment, or<5% blasts in presence of Auer rods or abnormal morphology -TF:Patient survives≥7 days following completion of initial 2 treatment cycles with persistent leukemia in the last peripheral blood smear or bone marrow or with persistent extramedullary disease - PD:Patient survives>7 days following completion of initial 2 treatment cycles with increase of blast population in bone marrow or peripheral blood by>50% or aggravation or new development of extramedullary disease or further deterioration or death due to leukemia | Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint. | Posted | Count of Participants | Participants | From first administration of study drug until the earliest of progressive disease (PD), death or last adequate disease assessment before new anti-cancer therapy, up to 299 days. |
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| Secondary | Progression Free Survival for Patients With Refractory or Relapsed Acute Myeloid Leukemia | Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death. | Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint. | Posted | Median | 95% Confidence Interval | Days | From first administration of study drug until progressed according to disease assessment, relapse, or death without progression, up to 167 days. |
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| Secondary | Time to Treatment Failure for Patients With Refractory or Relapsed Acute Myeloid Leukemia | Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy. | Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint. | Posted | Median | 95% Confidence Interval | Days | From first administration of study drug until progressive disease, relapse, death or start of next anti-AML therapy, up to 167 days. |
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| Secondary | Progression Free Survival for AML Patients in CR With High Risk to Relapse | Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death for AML patients in CR with high risk to relapse. | Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only AML patients in CR were included in the analysis. | Posted | Median | 95% Confidence Interval | Days | From first treatment with study drug until disease progression, relapse or death for AML patients in CR with high risk to relapse, up to 409 days. |
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| Secondary | Time to Treatment Failure for AML Patients in CR With High Risk to Relapse | Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy. | TS. Only patients in CR were included in the analysis. | Posted | Median | 95% Confidence Interval | Days | From first treatment with study drug until disease progression, relapse, death or start of next AML therapy for AML patients in CR with high risk to relapse, up to 409 days. |
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| Secondary | Maximum Measured Plasma Concentration (Cmax) | Maximum measured plasma concentration (Cmax) after the first infusion is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per millilitre (ng/ml) | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion. |
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| Secondary | Time From Dosing to the Maximum Plasma Concentration (Tmax) | Time from dosing to the maximum plasma concentration (tmax) after the first infusion is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Median | Full Range | hours (hrs) | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion. |
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval of One Week (AUC0-168) | Area under the plasma concentration-time curve over the time interval of one week (AUC0-168) after the first infusion is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/millilitre (ng*h/ml) | At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after BI 836858 infusion. |
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval of One Treatment Cycle (AUC0-tz) | Area under the plasma concentration-time curve over the time interval of one treatment cycle (AUC0-tz) is presented. One treatment cycle included a first and a second infusion. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/millilitre (ng*h/ml) | At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion. |
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-infinity) | Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-infinity) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/millilitre (ng*h/ml) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Terminal Half-life (t1/2) | Terminal half-life (t1/2) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours (hrs) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Mean Residence Time After Intravenous Infusion (MRT) | Mean residence time after intravenous infusion (MRT) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours (hrs) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Total Plasma Clearance (CL) | Total plasma clearance (CL) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | millilitre/minute (ml/min) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz) | Apparent volume of distribution during the terminal phase (Vz) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (l) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Volume of Distribution After Intravenous Infusion at Steady State (Vss) | Volume of distribution after intravenous infusion at steady state (Vss) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (l) | At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion. |
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable data point (AUC0-tz) is presented. | PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/millilitre (ng*h/ml) | At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion. |
|
All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML) | Patients with relapsed\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). | 2 | 12 | 9 | 12 | 12 | 12 |
| EG001 | BI 836858 20 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). | 4 | 8 | 8 | 8 | 8 | 8 |
| EG002 | BI 836858 40 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). | 2 | 7 | 6 | 7 | 7 | 7 |
| EG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Face pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Graft versus host disease in eye | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alpha haemolytic streptococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Illusion | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Discontinuation of prior anti-leukemia therapy was required at least 2 weeks before first administration of trial drug.
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 Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2018 | Jan 11, 2024 | SAP_001.pdf |
| 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 |
|---|---|
| C000621731 | BI 836858 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | BI 836858 40 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
Patients with relapsed\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
| OG001 | BI 836858 20 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| OG002 | BI 836858 40 mg (Patients With Relapsed\Refractory AML) | Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
|
|
|
|
|
|
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
|
|
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
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| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
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Patients with relapsed\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations). |
| OG003 | BI 836858 40 mg (Patients With AML in CR) | Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated. |
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