Trial Outcomes & Findings for Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC (NCT NCT00824408)
NCT ID: NCT00824408
Last Updated: 2016-09-20
Results Overview
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS \[days\] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS \[days, censored\] = date of last imaging showing no progression - date randomization + 1 day. The number of participants analysed displays the number of patients with an event (progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
From randomization until disease progression or death
Results posted on
2016-09-20
Participant Flow
Participant milestones
| Measure |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
|
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomized Phase: Volasertib 300 mg
Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
|
Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
|
Randomized Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Run-in Phase
STARTED
|
6
|
6
|
0
|
0
|
0
|
|
Run-in Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Run-in Phase
NOT COMPLETED
|
6
|
6
|
0
|
0
|
0
|
|
Randomized Phase
STARTED
|
0
|
0
|
37
|
47
|
47
|
|
Randomized Phase
COMPLETED
|
0
|
0
|
1
|
1
|
1
|
|
Randomized Phase
NOT COMPLETED
|
0
|
0
|
36
|
46
|
46
|
Reasons for withdrawal
| Measure |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
|
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomized Phase: Volasertib 300 mg
Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
|
Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
|
Randomized Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Run-in Phase
Progressive disease
|
4
|
4
|
0
|
0
|
0
|
|
Run-in Phase
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
|
Run-in Phase
Refused to continue medication
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Phase
Other reason not defined above
|
0
|
1
|
0
|
0
|
0
|
|
Randomized Phase
Not treated
|
0
|
0
|
1
|
1
|
1
|
|
Randomized Phase
Progressive disease
|
0
|
0
|
25
|
36
|
34
|
|
Randomized Phase
Adverse Event
|
0
|
0
|
4
|
5
|
5
|
|
Randomized Phase
Refused to continue medication
|
0
|
0
|
2
|
2
|
2
|
|
Randomized Phase
Other reason not defined above
|
0
|
0
|
4
|
2
|
4
|
Baseline Characteristics
Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
|
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg
n=37 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=47 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=47 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 6.83 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 10.26 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 8.89 • n=21 Participants
|
63.1 years
STANDARD_DEVIATION 9.12 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
70 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression or deathPopulation: Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS \[days\] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS \[days, censored\] = date of last imaging showing no progression - date randomization + 1 day. The number of participants analysed displays the number of patients with an event (progression).
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=34 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=43 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=39 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
|
1.4 months
Interval 1.2 to 1.9
|
3.3 months
Interval 1.9 to 5.7
|
5.3 months
Interval 3.1 to 7.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 daysPopulation: Randomized set
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=37 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=47 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=47 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Complete response (CR)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Partial response (PR)
|
16.7 percentage of participants
|
50.0 percentage of participants
|
8.1 percentage of participants
|
21.3 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until time of deathPopulation: Randomized phase II set, including only patients who died.
Overall survival (OS) was defined as the duration of time from randomization to time of death.
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=13 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=24 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=23 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
22.9 months
Interval 3.6 to
Not calculable due to insufficient data
|
17.1 months
Interval 9.4 to 28.8
|
17.4 months
Interval 10.3 to 34.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documentedPopulation: Randomized phase II set
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=10 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=31 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=32 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Duration of Overall Response
|
23.0 weeks
Interval 12.7 to 47.1
|
19.6 weeks
Interval 7.1 to 39.1
|
23.4 weeks
Interval 10.5 to 45.9
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 daysPopulation: Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=36 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=46 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Occurrence and Intensity of AEs Graded According to CTCAE.
CTCAE Grade 2
|
0 participants
|
2 participants
|
12 participants
|
18 participants
|
18 participants
|
|
Occurrence and Intensity of AEs Graded According to CTCAE.
CTCAE Grade 4
|
3 participants
|
1 participants
|
6 participants
|
5 participants
|
5 participants
|
|
Occurrence and Intensity of AEs Graded According to CTCAE.
CTCAE Grade 5
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
|
Occurrence and Intensity of AEs Graded According to CTCAE.
CTCAE Grade 1
|
0 participants
|
0 participants
|
6 participants
|
2 participants
|
6 participants
|
|
Occurrence and Intensity of AEs Graded According to CTCAE.
CTCAE Grade 3
|
3 participants
|
3 participants
|
8 participants
|
19 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.Population: Treated set, run-in phase, first course only
Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following: * treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment). * treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection. * CTCAE Grade 4 thrombocytopenia.
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Occurence of DLT
|
1 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 daysPopulation: On-treatment for lab
Frequency of patients with possible clinically significant abnormalities
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=36 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=46 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Haemoglobin - Low
|
1 participants
|
2 participants
|
16 participants
|
21 participants
|
14 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
White blood cell ct. - Low
|
4 participants
|
2 participants
|
15 participants
|
25 participants
|
12 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
White blood cell ct. - High
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Platelets - Low
|
0 participants
|
1 participants
|
8 participants
|
3 participants
|
2 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Platelets - High
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Neutrophils - Low
|
4 participants
|
2 participants
|
13 participants
|
23 participants
|
12 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Lymphocytes - Low
|
4 participants
|
4 participants
|
16 participants
|
22 participants
|
22 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
AST/GOT, SGOT - High
|
0 participants
|
1 participants
|
0 participants
|
6 participants
|
3 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
ALT/GPT, SGPT - High
|
0 participants
|
1 participants
|
0 participants
|
10 participants
|
6 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Alkaline phosphatase - High
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Creatinine - High
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Frequency of Patients With Possible Clinically Significant Abnormalities
Bilirubin, total - High
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusionPopulation: Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data
Cmax - maximum measured concentration of volasertib in plasma.
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=4 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=39 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=30 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Cmax of Volasertib
|
554 ng/mL
Geometric Coefficient of Variation 35.9
|
635 ng/mL
Geometric Coefficient of Variation 51.8
|
565 ng/mL
Geometric Coefficient of Variation 39.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusionPopulation: PK set including patients with evaluable data
CL - total clearance of volasertib in plasma after IV administration
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=30 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Total Clearance (CL) of Volasertib
|
782 mL/min
Geometric Coefficient of Variation 24.8
|
882 mL/min
Geometric Coefficient of Variation 30.4
|
867 mL/min
Geometric Coefficient of Variation 31.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusionPopulation: PK set including patients with evaluable data
Vss - apparent volume of distribution at steady state following IV administration of volasertib
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=30 Participants
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Vss of Volasertib
|
6730 Litres
Geometric Coefficient of Variation 42.1
|
6750 Litres
Geometric Coefficient of Variation 39.7
|
6230 Litres
Geometric Coefficient of Variation 34.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusionPopulation: PK set including patients with evaluable data
Cmax - maximum measured concentration of pemetrexed in plasma
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=6 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=38 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Cmax of Pemetrexed
|
131000 ng/mL
Geometric Coefficient of Variation 24.7
|
115000 ng/mL
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusionPopulation: PK set including patients with evaluable data
CL - total clearance of pemetrexed in plasma after IV administration
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=5 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=43 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
CL of Pemetrexed
|
54.4 mL/min
Geometric Coefficient of Variation 17.4
|
69.1 mL/min
Geometric Coefficient of Variation 30.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusionPopulation: PK set including patients with evaluable data
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
Outcome measures
| Measure |
Randomization Phase: Volasertib 300 mg
n=5 Participants
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=43 Participants
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Vss of Pemetrexed
|
9.40 Litres
Geometric Coefficient of Variation 20.5
|
13.1 Litres
Geometric Coefficient of Variation 45.8
|
—
|
—
|
—
|
Adverse Events
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Randomization Phase: Volasertib 300 mg
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
Serious events: 10 serious events
Other events: 46 other events
Deaths: 0 deaths
Randomization Phase: Pemetrexed 500 mg/m2
Serious events: 12 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
n=6 participants at risk
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
|
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 participants at risk
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg
n=36 participants at risk
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 participants at risk
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=46 participants at risk
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Acute myocardial infarction
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Chest pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Death
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Thrombosis in device
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
Other adverse events
| Measure |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2
n=6 participants at risk
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
|
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=6 participants at risk
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg
n=36 participants at risk
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2
n=46 participants at risk
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
|
Randomization Phase: Pemetrexed 500 mg/m2
n=46 participants at risk
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
|
|---|---|---|---|---|---|
|
General disorders
Catheter site pruritus
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Chest pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
50.0%
3/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
26.1%
12/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
25.0%
9/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Pancytopenia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
50.0%
3/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Eye disorders
Eye irritation
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Eye disorders
Eye oedema
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.0%
6/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
6/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
37.0%
17/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
21.7%
10/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
30.4%
14/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
26.1%
12/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Lip blister
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
66.7%
4/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.9%
5/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
47.8%
22/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
54.3%
25/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.4%
7/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
32.6%
15/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
23.9%
11/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Chills
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Fatigue
|
83.3%
5/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
100.0%
6/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
55.6%
20/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
71.7%
33/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
69.6%
32/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
17.4%
8/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Injection site discomfort
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Injection site pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
28.3%
13/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Puncture site haemorrhage
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
General disorders
Pyrexia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Candidiasis
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Herpes zoster
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
17.4%
8/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Respiratory tract infection
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood albumin decreased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Carbohydrate antigen 125 increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Creatinine renal clearance decreased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Neutrophil count increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Weight decreased
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
Weight increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
66.7%
4/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
43.5%
20/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
41.3%
19/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Metabolism and nutrition disorders
Hypophagia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.0%
6/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
12/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
28.3%
13/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.0%
6/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
50.0%
3/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.9%
5/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Convulsion
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
50.0%
3/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.4%
7/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
17.4%
8/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.0%
6/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Psychiatric disorders
Abnormal dreams
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
15.2%
7/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.9%
5/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
19.6%
9/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
21.7%
10/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
6/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
26.1%
12/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
23.9%
11/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.9%
5/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.3%
3/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
10.9%
5/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
8.7%
4/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
13.9%
5/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
5.6%
2/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.8%
1/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
17.4%
8/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
11.1%
4/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
30.4%
14/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
26.1%
12/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
16.7%
1/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
6.5%
3/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/6 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
0.00%
0/36 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
2.2%
1/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
4.3%
2/46 • From first drug infusion until 21 days after last drug infusion, up to 1100 days
|
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