Trial Outcomes & Findings for Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known (NCT NCT01971476)
NCT ID: NCT01971476
Last Updated: 2018-07-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Up to 14 days.
Results posted on
2018-07-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Cohort 1: 2 to <12 Years
STARTED
|
3
|
3
|
6
|
|
Cohort 1: 2 to <12 Years
COMPLETED
|
0
|
0
|
0
|
|
Cohort 1: 2 to <12 Years
NOT COMPLETED
|
3
|
3
|
6
|
|
Cohort 2: 12 to <18 Years
STARTED
|
6
|
4
|
0
|
|
Cohort 2: 12 to <18 Years
COMPLETED
|
0
|
0
|
0
|
|
Cohort 2: 12 to <18 Years
NOT COMPLETED
|
6
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Cohort 1: 2 to <12 Years
Other not defined
|
3
|
3
|
6
|
|
Cohort 2: 12 to <18 Years
Other not defined
|
6
|
3
|
0
|
|
Cohort 2: 12 to <18 Years
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
Baseline characteristics by cohort
| Measure |
Volasertib 200 mg/m2
n=9 Participants
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.
|
Volasertib 250 mg/m2
n=7 Participants
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.
|
Volasertib 300 mg/m2
n=6 Participants
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
2 to <12 years
|
7.0 Years
STANDARD_DEVIATION 3.6 • n=93 Participants
|
6.3 Years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
7.0 Years
STANDARD_DEVIATION 3.3 • n=27 Participants
|
6.8 Years
STANDARD_DEVIATION 3.0 • n=483 Participants
|
|
Age, Continuous
12 to <18 years
|
14.3 Years
STANDARD_DEVIATION 2.3 • n=93 Participants
|
15.8 Years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=27 Participants
|
14.9 Years
STANDARD_DEVIATION 2.1 • n=483 Participants
|
|
Sex/Gender, Customized
Female (2 to <12 years)
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Male (2 to <12 years)
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Female (12 to <18 years)
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Male (12 to <18 years)
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days.Population: 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.
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).
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=12 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=10 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Volasertib
|
300 mg
|
200 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 879 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Hepatobiliary disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Hyperbilirubinaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Total AEs in grouped category hepatic impairment
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Blood alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Metabolism and nutrition disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Gamma-glutamyltransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 879 days.Population: 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.
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).
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
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
Total AEs clinically relevant changes of calcium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
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
Metabolism and nutrition disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
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
Hypocalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
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
Hypercalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 879 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
Total AEs in the MedDRA SMQ of QT prolongation
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
Cardiac disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations
Conduction disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 849 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=2 Participants
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.
|
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
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
Complete remission
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
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
CRi*
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
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
Partial remission
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
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
Stable disease
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
|
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
Progressive disease
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
|
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
Death in aplasia
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
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
Not evaluable
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
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
Missing
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 849 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=2 Participants
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.
|
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Event-Free Survival (EFS) [in Leukaemia Patients]
|
NA Months
Median EFS not estimated due to small number of patients per treatment arm.
|
NA Months
Median EFS not estimated due to small number of patients per treatment arm.
|
—
|
NA Months
Median EFS not estimated due to small number of patients per treatment arm.
|
NA Months
Median EFS not estimated due to small number of patients per treatment arm.
|
—
|
SECONDARY outcome
Timeframe: Up to 849 days.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=2 Participants
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.
|
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=2 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) [in Leukaemia Patients]
|
NA Months
Median OS not estimated due to small number of patients per treatment arm.
|
NA Months
Median OS not estimated due to small number of patients per treatment arm.
|
—
|
NA Months
Median OS not estimated due to small number of patients per treatment arm.
|
NA Months
Median OS not estimated due to small number of patients per treatment arm.
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration (Cmax, Norm) of Volasertib
|
5.34 ng/mL/mg
Geometric Coefficient of Variation 22.0
|
9.71 ng/mL/mg
Geometric Coefficient of Variation 128
|
3.60 ng/mL/mg
Geometric Coefficient of Variation 35.1
|
2.46 ng/mL/mg
Geometric Coefficient of Variation 54.9
|
2.50 ng/mL/mg
Geometric Coefficient of Variation 94.6
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=2 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Trough Concentration (Cpre, 2) of Volasertib
|
1.48 ng/mL
Geometric Coefficient of Variation 60.3
|
1.13 ng/mL
Geometric Coefficient of Variation 17.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma
|
41.7 ng*h/mL/mg
Geometric Coefficient of Variation 40.1
|
51.2 ng*h/mL/mg
Geometric Coefficient of Variation 69.8
|
36.4 ng*h/mL/mg
Geometric Coefficient of Variation 28.2
|
28.6 ng*h/mL/mg
Geometric Coefficient of Variation 19.0
|
22.1 ng*h/mL/mg
Geometric Coefficient of Variation 37.9
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
This outcome measure presents half-life of Volasertib.
Outcome measures
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 Participants
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 Participants
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Half-Life (t1/2) of Volasertib
|
102 h
Geometric Coefficient of Variation 28.6
|
130 h
Geometric Coefficient of Variation 14.1
|
54.8 h
Geometric Coefficient of Variation 27.2
|
78.6 h
Geometric Coefficient of Variation 27.3
|
52.7 h
Geometric Coefficient of Variation 17.7
|
—
|
Adverse Events
2 to <12 Years: Volasertib 200 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
2 to <12 Years: Volasertib 250 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
2 to <12 Years: Volasertib 300 mg/m2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
2 to <12 Years: Volasertib Pooled Total
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
12 to <18 Years: Volasertib 200 mg/m2
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
12 to <18 Years: Volasertib 250 mg/m2
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
12 to <18 Years: Volasertib Pooled Total
Serious events: 10 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 participants at risk
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 participants at risk
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 participants at risk
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.
|
2 to <12 Years: Volasertib Pooled Total
n=12 participants at risk
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 participants at risk
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 participants at risk
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.
|
12 to <18 Years: Volasertib Pooled Total
n=10 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Abscess neck
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
3/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
41.7%
5/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
40.0%
4/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
Other adverse events
| Measure |
2 to <12 Years: Volasertib 200 mg/m2
n=3 participants at risk
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.
|
2 to <12 Years: Volasertib 250 mg/m2
n=3 participants at risk
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.
|
2 to <12 Years: Volasertib 300 mg/m2
n=6 participants at risk
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.
|
2 to <12 Years: Volasertib Pooled Total
n=12 participants at risk
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.
|
12 to <18 Years: Volasertib 200 mg/m2
n=6 participants at risk
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.
|
12 to <18 Years: Volasertib 250 mg/m2
n=4 participants at risk
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.
|
12 to <18 Years: Volasertib Pooled Total
n=10 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Investigations
International normalised ration increased
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
3/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
66.7%
2/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
3/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
6/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
30.0%
3/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Anal inflammation
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Chills
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Cranial nerve disorder
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
3/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Fatigue
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
30.0%
3/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Malaise
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
40.0%
4/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
3/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
4/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
3/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
40.0%
4/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
General disorders
Pyrexia
|
66.7%
2/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
2/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
20.0%
2/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
66.7%
2/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
3/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
3/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
40.0%
4/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
8.3%
1/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
3/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
33.3%
2/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
50.0%
2/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
40.0%
4/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
16.7%
1/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/3 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/12 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
0.00%
0/6 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
25.0%
1/4 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
10.0%
1/10 • From the first drug administration until 30 days after the last drug administration.
Treated Set
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER