Open Dose Escalating Trial to Determine the Maximum Toler... | NCT01971476 | Trialant
NCT01971476
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jul 30, 2018Actual
Enrollment
22Actual
Phase
Phase 1
Conditions
Leukemia
Neoplasms
Interventions
volasertib
Countries
Belgium
Czechia
France
Germany
Italy
Protocol Section
Identification Module
NCT ID
NCT01971476
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1230.27
Secondary IDs
ID
Type
Description
Link
2013-001291-38
EudraCT Number
Brief Title
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
Official Title
Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Oct 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 22, 2013Actual
Primary Completion Date
Jun 1, 2015Actual
Completion Date
Jan 27, 2017Actual
First Submitted Date
Oct 10, 2013
First Submission Date that Met QC Criteria
Oct 24, 2013
First Posted Date
Oct 29, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2017
Results First Submitted that Met QC Criteria
Oct 24, 2017
Results First Posted Date
Jul 30, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 24, 2017
Last Update Posted Date
Jul 30, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients
Detailed Description
Not provided
Conditions Module
Conditions
Leukemia
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
22Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
All patients
Experimental
Volasertib will be administered as intravenous infusion
Drug: volasertib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
volasertib
Drug
intravenous administration on day 1of a treatment course
All patients
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLTs were defined as drug related Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (haematological and nonhaematological) Adverse Events (AEs) with the exception of a) Reduced blood cell count (any grade) without associated clinical complications qualifying for DLT. b) Febrile neutropenia Grade 3. c) Infection Grade 3 with neutrophil count <1000/mm3. d) Uric acid Grade ≥3. e) Nausea, vomiting and/or diarrhoea managed by adequate therapy (i.e. recovery to CTCAE Grade ≤2).
Up to 14 days.
Maximum Tolerated Dose of Volasertib
This outcome measure presents MTD of Volasertib. The MTD was defined as the highest dose level at which DLTs were reported in not more than 1 in 6 evaluable patients during Cycle 1.
Up to 14 days.
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
This outcome measure presents number of patients with hepatic injury defined as AESI. Hepatic injury was defined by the following alterations of liver parameters: an elevation of Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3x Upper Limit of Normal (ULN) combined with an elevation of total bilirubin >2x ULN measured in the same blood sample.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known
Lansky score > 60 for children 2 to less than 12 years
Karnofsky score > 60 for children aged 12 or older
life expectancy of at least 6 weeks as judged by the investigator
parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained
Exclusion criteria:
patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy
presence of cardiac disease (LVEF by echocardiography less than 25 %)
symptomatic Central Nervous System involvement of the malignant disease
primary CNS tumour
inadequate lab parameters
inadequate venous access
QTc prolongation
pregnancy, breastfeeding
other diseases or CTs that might interfere with evaluation of safety
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UNIV UZ Gent
Ghent
9000
Belgium
University Hospital Motol
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
In the age group 2 to <12 years, 15 patients were screened, with 3 screen failures. In the age group 12 to <18 years, 14 patients were screened, with 4 screen failures.
Recruitment Details
In the age group 2 to <12 years, 12 patients were entered and treated. In the age group 12 to <18 years, 10 patients were entered and treated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour (h) on Day 1 of 14-day cycle.
FG001
Volasertib 250 mg/m2
Periods
Title
Milestones
Reasons Not Completed
Cohort 1: 2 to <12 Years
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Netherlands
Slovakia
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Up to 879 days.
Number of Patients With Clinically Relevant Laboratory Value Changes of Calcium (Hyper- and/or Hypocalcaemia) as Judged by the Investigator and Reported as AEs, CTCAE Grade ≥3
This outcome measure presents number of patients with clinically relevant laboratory value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as AEs, CTCAE Grade ≥3. CTCAE Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Up to 879 days.
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
This outcome measure presents the number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations to assess cardiac activity based on Electrocardiogram (ECG) recordings (digital, triplicate) before and at the end of each Volasertib administration and at least at 2 more time points within the first 24 hours after end of the first Volasertib administration. Two methods of heart rate correction of the QT interval were used: the fixed corrections Fridericia's correction (QTcF) and Bazett's correction (QTcB).
SMQ: Standardised Medical Dictionary for Regulatory Activities (MedDRA) query.
Up to 879 days.
Best Overall Response [in Leukaemia Patients]: (Complete Remission (CR)), CR With Incomplete Neutrophil or Platelet Recovery (CRi), Partial Remission (PR), Stable Disease (SD), Progressive Disease (PD) and Death in Aplasia
This outcome measure includes, CR: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary (EM) disease; absolute neutrophil count ≥ 1.0 x 109/L (1000/μL); platelet count ≥80 x 109/L (80000/μL); independence of red blood cells transfusions. CRi: All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<800 x 109/L [80000/μL]), independence of red blood cell transfusions not required. PR: Decrease of bone marrow blast percentage to 5%-25%; decrease of pretreatment bone marrow (baseline) blast percentage by at least 50%; absence of EM disease. SD: Neither qualifies for CR, CRi, PR or PD. PD: At least one of the criteria a) 50% increase in bone marrow blast count over baseline b) 50% increase in peripheral blast count over baseline - evidence of new EM disease - clinically PD based on the judgment of the investigator. Death in aplasia: Deaths occurring ≥7 days after last administration of the trial drug while cytopenic.
Up to 849 days.
Event-Free Survival (EFS) [in Leukaemia Patients]
EFS was defined as the time from the first infusion of Volasertib to the date of PD or relapse, occurrence of secondary malignancy, or death from any cause, whichever occurred first. EFS was censored at the date of last disease assessment for patients who were not reported with PD, relapse, occurrence of secondary malignancy or death.
Up to 849 days.
Overall Survival (OS) [in Leukaemia Patients]
Overall survival was defined as time from first infusion of Volasertib to death from any cause. For patients who were lost to follow-up, OS were censored on the last date the patients were known to be alive.
Up to 849 days.
Maximum Measured Concentration (Cmax, Norm) of Volasertib
This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
Trough Concentration (Cpre, 2) of Volasertib
This outcome measure presents pre-dose concentration of Volasertib in plasma immediately before administration of the second dose (Cpre,2).
The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma
This outcome measure presents dose normalized area under the concentration-time curve of Volasertib in plasma over the time interval from zero extrapolated to infinity.
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
Half-Life (t1/2) of Volasertib
This outcome measure presents half-life of Volasertib.
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
Prague
150 06
Czechia
INS Curie
Paris
75248
France
Universitätsklinikum Köln (AöR)
Cologne
50937
Germany
Osp. Pediatrico Bambin Gesù
Roma
00165
Italy
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
FG002
Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
FG0003 subjects
FG0013 subjects
FG0026 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
Type
Comment
Reasons
Other not defined
FG0003 subjects
FG0013 subjects
FG0026 subjects
Cohort 2: 12 to <18 Years
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0014 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG0006 subjects
FG0014 subjects
FG0020 subjects
Type
Comment
Reasons
Other not defined
FG0006 subjects
FG0013 subjects
FG0020 subjects
Adverse Event
FG000
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
2 to <12 years (N=3, 3, 6). 12 to < 18 years (N=6, 4, 0).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
BG001
Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
BG002
Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0017
BG0026
BG00322
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
2 to <12 years
Title
Measurements
BG0007.0± 3.6
BG0016.3± 3.1
BG0027.0± 3.3
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Female (2 to <12 years)
Title
Measurements
BG0001
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLTs were defined as drug related Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (haematological and nonhaematological) Adverse Events (AEs) with the exception of a) Reduced blood cell count (any grade) without associated clinical complications qualifying for DLT. b) Febrile neutropenia Grade 3. c) Infection Grade 3 with neutrophil count <1000/mm3. d) Uric acid Grade ≥3. e) Nausea, vomiting and/or diarrhoea managed by adequate therapy (i.e. recovery to CTCAE Grade ≤2).
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
Posted
Number
Participants
Up to 14 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Maximum Tolerated Dose of Volasertib
This outcome measure presents MTD of Volasertib. The MTD was defined as the highest dose level at which DLTs were reported in not more than 1 in 6 evaluable patients during Cycle 1.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
Posted
Number
mg
Up to 14 days.
ID
Title
Description
OG000
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
This outcome measure presents number of patients with hepatic injury defined as AESI. Hepatic injury was defined by the following alterations of liver parameters: an elevation of Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3x Upper Limit of Normal (ULN) combined with an elevation of total bilirubin >2x ULN measured in the same blood sample.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
Posted
Number
Participants
Up to 879 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Number of Patients With Clinically Relevant Laboratory Value Changes of Calcium (Hyper- and/or Hypocalcaemia) as Judged by the Investigator and Reported as AEs, CTCAE Grade ≥3
This outcome measure presents number of patients with clinically relevant laboratory value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as AEs, CTCAE Grade ≥3. CTCAE Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
Posted
Number
Participants
Up to 879 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
This outcome measure presents the number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations to assess cardiac activity based on Electrocardiogram (ECG) recordings (digital, triplicate) before and at the end of each Volasertib administration and at least at 2 more time points within the first 24 hours after end of the first Volasertib administration. Two methods of heart rate correction of the QT interval were used: the fixed corrections Fridericia's correction (QTcF) and Bazett's correction (QTcB).
SMQ: Standardised Medical Dictionary for Regulatory Activities (MedDRA) query.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
Posted
Number
Participants
Up to 879 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Best Overall Response [in Leukaemia Patients]: (Complete Remission (CR)), CR With Incomplete Neutrophil or Platelet Recovery (CRi), Partial Remission (PR), Stable Disease (SD), Progressive Disease (PD) and Death in Aplasia
This outcome measure includes, CR: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary (EM) disease; absolute neutrophil count ≥ 1.0 x 109/L (1000/μL); platelet count ≥80 x 109/L (80000/μL); independence of red blood cells transfusions. CRi: All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<800 x 109/L [80000/μL]), independence of red blood cell transfusions not required. PR: Decrease of bone marrow blast percentage to 5%-25%; decrease of pretreatment bone marrow (baseline) blast percentage by at least 50%; absence of EM disease. SD: Neither qualifies for CR, CRi, PR or PD. PD: At least one of the criteria a) 50% increase in bone marrow blast count over baseline b) 50% increase in peripheral blast count over baseline - evidence of new EM disease - clinically PD based on the judgment of the investigator. Death in aplasia: Deaths occurring ≥7 days after last administration of the trial drug while cytopenic.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Posted
Number
Participants
Up to 849 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Event-Free Survival (EFS) [in Leukaemia Patients]
EFS was defined as the time from the first infusion of Volasertib to the date of PD or relapse, occurrence of secondary malignancy, or death from any cause, whichever occurred first. EFS was censored at the date of last disease assessment for patients who were not reported with PD, relapse, occurrence of secondary malignancy or death.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Posted
Median
95% Confidence Interval
Months
Up to 849 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Overall Survival (OS) [in Leukaemia Patients]
Overall survival was defined as time from first infusion of Volasertib to death from any cause. For patients who were lost to follow-up, OS were censored on the last date the patients were known to be alive.
Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.
The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Posted
Median
95% Confidence Interval
Months
Up to 849 days.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Maximum Measured Concentration (Cmax, Norm) of Volasertib
This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).
Pharmacokinetic Set (PKS): All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Trough Concentration (Cpre, 2) of Volasertib
This outcome measure presents pre-dose concentration of Volasertib in plasma immediately before administration of the second dose (Cpre,2).
The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data. The number of participants analysed are the number of participants with available data at the timepoint of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Secondary
Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma
This outcome measure presents dose normalized area under the concentration-time curve of Volasertib in plasma over the time interval from zero extrapolated to infinity.
Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL/mg
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
Secondary
Half-Life (t1/2) of Volasertib
This outcome measure presents half-life of Volasertib.
Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.
Posted
Geometric Mean
Geometric Coefficient of Variation
h
Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.
ID
Title
Description
OG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Time Frame
From the first drug administration until 30 days after the last drug administration.
Description
Treated Set
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
2 to <12 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
1
3
3
3
EG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
1
3
3
3
EG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
5
6
6
6
EG003
2 to <12 Years: Volasertib Pooled Total
The pooled total of patients administered Volasertib 200 mg/m2/250 mg/m2/300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
7
12
12
12
EG004
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
6
6
6
6
EG005
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 1-day cycle.
4
4
3
4
EG006
12 to <18 Years: Volasertib Pooled Total
The pooled total of patients administered Volasertib 200 mg/m2/250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
10
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG0030 affected12 at risk
EG0040 affected6 at risk
EG0051 affected4 at risk
EG0061 affected10 at risk
Abscess neck
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0023 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bone marrow toxicity
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tongue injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Activated partial thromboplastin time prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG0031 affected12 at risk
EG004
Alanine aminotransferase decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Antithrombin III decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatine increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatine phosphokinase MB increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood pressure increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Body temperature increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
International normalised ration increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0023 affected6 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Cranial nerve disorder
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Malaise
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mechanical urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0023 affected6 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D007938
Leukemia
D009369
Neoplasms
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541363
BI 6727
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0011 subjects
FG0020 subjects
6.8
± 3.0
12 to <18 years
Title
Measurements
BG00014.3± 2.3
BG00115.8± 1.5
BG002NA± NANo patients entered.
BG00314.9± 2.1
3
BG0036
Male (2 to <12 years)
Title
Measurements
BG0002
BG0011
BG0023
BG0036
Female (12 to <18 years)
Title
Measurements
BG0002
BG0010
BG0020
BG0032
Male (12 to <18 years)
Title
Measurements
BG0004
BG0014
BG0020
BG0038
6
OG0044
OG0050
0
OG0042
12
OG00110
Title
Denominators
Categories
Title
Measurements
OG000300
OG001200
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0044
OG0050
Title
Denominators
Categories
Total AEs in grouped category hepatic impairment
Title
Measurements
OG0000
OG0011
OG0021
OG0033
OG0041
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Metabolism and nutrition disorders
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hepatobiliary disorders
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperbilirubinaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0044
OG0050
Title
Denominators
Categories
Total AEs clinically relevant changes of calcium
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Metabolism and nutrition disorders
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0044
OG0050
Title
Denominators
Categories
Total AEs in the MedDRA SMQ of QT prolongation
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0041
Electrocardiogram QT prolonged
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cardiac disorders
Title
Measurements
OG0000
OG0010
OG0020
OG003
Conduction disorder
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
2 to <12 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0002
OG0012
OG0020
OG0032
OG0041
OG0050
Title
Denominators
Categories
Complete remission
Title
Measurements
OG0000
OG0010
OG0030
OG0040
CRi*
Title
Measurements
OG0000
OG0010
OG0030
OG004
Partial remission
Title
Measurements
OG0000
OG0010
OG0030
OG004
Stable disease
Title
Measurements
OG0002
OG0012
OG0031
OG004
Progressive disease
Title
Measurements
OG0000
OG0010
OG0031
OG004
Death in aplasia
Title
Measurements
OG0000
OG0010
OG0030
OG004
Not evaluable
Title
Measurements
OG0000
OG0010
OG0030
OG004
Missing
Title
Measurements
OG0000
OG0010
OG0030
OG004
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0002
OG0012
OG0020
OG0032
OG0041
OG0050
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median EFS not estimated due to small number of patients per treatment arm.
OG001NA(NA to NA)Median EFS not estimated due to small number of patients per treatment arm.
OG003NA(NA to NA)Median EFS not estimated due to small number of patients per treatment arm.
OG004NA(NA to NA)Median EFS not estimated due to small number of patients per treatment arm.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0002
OG0012
OG0020
OG0032
OG0041
OG0050
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median OS not estimated due to small number of patients per treatment arm.
OG001NA(NA to NA)Median OS not estimated due to small number of patients per treatment arm.
OG003NA(NA to NA)Median OS not estimated due to small number of patients per treatment arm.
OG004NA(NA to NA)Median OS not estimated due to small number of patients per treatment arm.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG0005.34± 22.0
OG0019.71± 128
OG0023.60± 35.1
OG0032.46± 54.9
OG0042.50± 94.6
OG002
2 to <12 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0012
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0001.48± 60.3
OG0011.13± 17.6
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG00041.7± 40.1
OG00151.2± 69.8
OG00236.4± 28.2
OG00328.6± 19.0
OG00422.1± 37.9
OG003
12 to <18 Years: Volasertib 200 mg/m2
The patients were administered Volasertib 200 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG004
12 to <18 Years: Volasertib 250 mg/m2
The patients were administered Volasertib 250 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.
OG005
12 to <18 Years: Volasertib 300 mg/m2
The patients were administered Volasertib 300 mg/m2 (solution for infusion) by intravenous infusion over approximately 1 hour on Day 1 of 14-day cycle.