Neoplasms
Conditions
Brief summary
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin). Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.
Interventions
DRUGBI-6727
Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added
DRUGBI 6727
low to high dose
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment 2. Indication for a treatment with platinum therapy as judged by the investigator 3. Age 18 years or older 4. Written informed consent consistent with ICH-GCP and local legislation 5. ECOG performance score lower or equal 2 6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)
Exclusion criteria
1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol 2. Pregnancy or breastfeeding 3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II 4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months 5. Second malignancy currently requiring another anti-cancer therapy 6. ANC less than 1500 / mm3 7. Platelet count less than 100 000 / mm3 8. Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome) 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) 10. Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent) or creatinine clearance \<70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate) 11. Known history of relevant QT-prolongation, e.g. long QT-syndrome 12. Pre-existing clinically relevant hearing loss 13. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception 14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial 15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates. 16. Patients unable to comply with the protocol 17. Active alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | 3 weeks | The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0). Tumour response was documented using appropriate techniques |
| Duration of Objective Response | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria. Tumour response was documented using appropriate techniques |
| Best Overall Response | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria. |
| Disease Control Rate | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria. |
| Duration of Disease Control | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first. |
| Progression-free Survival | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first. |
| Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0 |
| Percentage of Participants With Serious Adverse Events | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with serious adverse events (AEs) |
| Percentage of Participants With Significant Adverse Events | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE. DLTs (i.e. significant AEs) per protocol were: * drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity) * drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection * drug related CTCAE Grade 4 thrombocytopenia * drug related febrile neutropenia grade 3 (ANC\<1000/mm³ and fever≥ 38.5°C) |
| Total Plasma Clearance After Intravascular Administration (CL) | 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion | Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1. |
| Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion | Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1. |
| Percentage of Participants With Dose Limiting Toxicities | 3 weeks | Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle. |
| Change From Baseline in Neutrophils | Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Change from baseline in neutrophils with the maximum value on treatment |
| Change From Baseline in Platelets | Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Change from baseline in platelets with the maximum value on treatment |
| Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils \>=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets \>=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment. Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment. Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE) |
| Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment. Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment. Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE) |
| Worst CTCAE Grade on Treatment for Platelets | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Worst CTCAE Grade on Treatment for Neutrophils | From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE). |
| Change From Baseline in Pulse Rate | Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days | Change from baseline in pulse rate at last value on treatment |
Countries
Belgium
Participant flow
Recruitment details
An open-label, parallel group, 3+3 dose escalation trial Volasertib and cisplatin or carboplatin combination therapy was given on Day 1 of up to 6, 3-week cycles.
Pre-assignment details
For the carboplatin arm, the target doses were calculated using the Calvert formula to achieve AUC 4, AUC 5 and AUC 6. Calvert formula: Dose (mg) = target AUC x (glomerular filtration rate (GFR) + 25); GFR = (140 - age \[years\]) x (actual weight \[kg\])/(72 x serum creatinine \[mg/dL\]). Multiply by another factor of 0.85 if female).
Participants by arm
| Arm | Count |
|---|---|
| V200+Cis75 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V300+Cis75 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V300+Cis100 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 12 |
| V350+Cis75 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 6 |
| V100+Car4 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V100+Car5 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V200+Car5 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V300+Car5 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 6 |
| V300+Car6 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 13 |
| V350+Car5 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V100+Cis60 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| V100+Cis75 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle. | 3 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Discont. Before Start of Treat. Cycle 2 | Dose Limiting Toxicity (DLT) | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discont. Before Start of Treat. Cycle 2 | Other adverse events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discont. Before Start of Treat. Cycle 2 | Progressive Disease | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Discont. Before Start of Treat. Cycle 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Treated in and Beyond Treat. Cycle 2 | Other adverse events | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Treated in and Beyond Treat. Cycle 2 | Progressive disease | 2 | 3 | 10 | 3 | 2 | 3 | 3 | 6 | 9 | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | V200+Cis75 | V300+Cis75 | V300+Cis100 | V350+Cis75 | V100+Car4 | V100+Car5 | V200+Car5 | V300+Car5 | V300+Car6 | V350+Car5 | V100+Cis60 | V100+Cis75 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.7 Years STANDARD_DEVIATION 7.51 | 55.0 Years STANDARD_DEVIATION 12.53 | 52.5 Years STANDARD_DEVIATION 16.67 | 60.0 Years STANDARD_DEVIATION 9.53 | 56.3 Years STANDARD_DEVIATION 11.72 | 54.0 Years STANDARD_DEVIATION 5.57 | 58.0 Years STANDARD_DEVIATION 13.75 | 66.3 Years STANDARD_DEVIATION 10.07 | 51.8 Years STANDARD_DEVIATION 13.03 | 58.3 Years STANDARD_DEVIATION 6.66 | 45.0 Years STANDARD_DEVIATION 19.16 | 58.3 Years STANDARD_DEVIATION 7.37 | 54.7 Years STANDARD_DEVIATION 13.08 |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 9 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 7 Participants | 1 Participants | 1 Participants | 1 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 12 / 12 | 6 / 6 | 3 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 13 / 13 | 3 / 3 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 1 / 3 | 6 / 12 | 3 / 6 | 1 / 3 | 0 / 3 | 1 / 3 | 1 / 6 | 6 / 13 | 2 / 3 | 2 / 3 | 1 / 3 |
Outcome results
Primary
Maximum Tolerated Dose
The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose.
Time frame: 3 weeks
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Maximum Tolerated Dose | 0 Units on a scale |
| V100+Cis75 | Maximum Tolerated Dose | 0 Units on a scale |
| V200+Cis75 | Maximum Tolerated Dose | 0 Units on a scale |
| V300+Cis75 | Maximum Tolerated Dose | 0 Units on a scale |
| V300+Cis100 | Maximum Tolerated Dose | 1 Units on a scale |
| V350+Cis75 | Maximum Tolerated Dose | 0 Units on a scale |
| V100+Car4 | Maximum Tolerated Dose | 0 Units on a scale |
| V100+Car5 | Maximum Tolerated Dose | 0 Units on a scale |
| V200+Car5 | Maximum Tolerated Dose | 0 Units on a scale |
| V300+Car5 | Maximum Tolerated Dose | 0 Units on a scale |
| V300+Car6 | Maximum Tolerated Dose | 1 Units on a scale |
| V350+Car5 | Maximum Tolerated Dose | 0 Units on a scale |
Secondary
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
Time frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 6580 Litres | Geometric Coefficient of Variation 66.9 |
| V100+Cis75 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 11100 Litres | Geometric Coefficient of Variation 20.1 |
| V200+Cis75 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 5570 Litres | Geometric Coefficient of Variation 18.9 |
| V300+Cis75 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 7140 Litres | Geometric Coefficient of Variation 42.5 |
| V300+Cis100 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 5880 Litres | Geometric Coefficient of Variation 67.6 |
| V350+Cis75 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 7270 Litres | Geometric Coefficient of Variation 41.5 |
| V100+Car4 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 8810 Litres | Geometric Coefficient of Variation 38.7 |
| V100+Car5 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 9960 Litres | Geometric Coefficient of Variation 44.7 |
| V200+Car5 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 8950 Litres | Geometric Coefficient of Variation 36.9 |
| V300+Car5 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 8270 Litres | Geometric Coefficient of Variation 42.2 |
| V300+Car6 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 7440 Litres | Geometric Coefficient of Variation 31.9 |
| V350+Car5 | Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) | 3640 Litres | Geometric Coefficient of Variation 35.9 |
Secondary
Best Overall Response
Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Best Overall Response | Progressive disease | 33.3 Percentage of participants |
| V100+Cis60 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V100+Cis60 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V100+Cis60 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V100+Cis60 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V100+Cis60 | Best Overall Response | Stable disease | 66.7 Percentage of participants |
| V100+Cis75 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V100+Cis75 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V100+Cis75 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V100+Cis75 | Best Overall Response | Stable disease | 66.7 Percentage of participants |
| V100+Cis75 | Best Overall Response | Partial response | 33.3 Percentage of participants |
| V100+Cis75 | Best Overall Response | Progressive disease | 0.0 Percentage of participants |
| V200+Cis75 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V200+Cis75 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V200+Cis75 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V200+Cis75 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V200+Cis75 | Best Overall Response | No post-baseline tumour assessment | 33.3 Percentage of participants |
| V200+Cis75 | Best Overall Response | Progressive disease | 33.3 Percentage of participants |
| V300+Cis75 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V300+Cis75 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V300+Cis75 | Best Overall Response | Partial response | 33.3 Percentage of participants |
| V300+Cis75 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V300+Cis75 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V300+Cis75 | Best Overall Response | Progressive disease | 33.3 Percentage of participants |
| V300+Cis100 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V300+Cis100 | Best Overall Response | No post-baseline tumour assessment | 16.7 Percentage of participants |
| V300+Cis100 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V300+Cis100 | Best Overall Response | Stable disease | 25.0 Percentage of participants |
| V300+Cis100 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V300+Cis100 | Best Overall Response | Progressive disease | 58.3 Percentage of participants |
| V350+Cis75 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V350+Cis75 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V350+Cis75 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V350+Cis75 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V350+Cis75 | Best Overall Response | Progressive disease | 50.0 Percentage of participants |
| V350+Cis75 | Best Overall Response | No post-baseline tumour assessment | 16.7 Percentage of participants |
| V100+Car4 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V100+Car4 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V100+Car4 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V100+Car4 | Best Overall Response | Progressive disease | 66.7 Percentage of participants |
| V100+Car4 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V100+Car4 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V100+Car5 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V100+Car5 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V100+Car5 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V100+Car5 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V100+Car5 | Best Overall Response | Progressive disease | 66.7 Percentage of participants |
| V100+Car5 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V200+Car5 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V200+Car5 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V200+Car5 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V200+Car5 | Best Overall Response | Progressive disease | 100.0 Percentage of participants |
| V200+Car5 | Best Overall Response | Stable disease | 0.0 Percentage of participants |
| V200+Car5 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V300+Car5 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V300+Car5 | Best Overall Response | Progressive disease | 33.3 Percentage of participants |
| V300+Car5 | Best Overall Response | Partial response | 16.7 Percentage of participants |
| V300+Car5 | Best Overall Response | Non evaluable | 16.7 Percentage of participants |
| V300+Car5 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V300+Car5 | Best Overall Response | No post-baseline tumour assessment | 0.0 Percentage of participants |
| V300+Car6 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V300+Car6 | Best Overall Response | Stable disease | 7.7 Percentage of participants |
| V300+Car6 | Best Overall Response | Partial response | 7.7 Percentage of participants |
| V300+Car6 | Best Overall Response | Progressive disease | 61.5 Percentage of participants |
| V300+Car6 | Best Overall Response | No post-baseline tumour assessment | 23.1 Percentage of participants |
| V300+Car6 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V350+Car5 | Best Overall Response | Stable disease | 33.3 Percentage of participants |
| V350+Car5 | Best Overall Response | Non evaluable | 0.0 Percentage of participants |
| V350+Car5 | Best Overall Response | Complete response | 0.0 Percentage of participants |
| V350+Car5 | Best Overall Response | Partial response | 0.0 Percentage of participants |
| V350+Car5 | Best Overall Response | Progressive disease | 33.3 Percentage of participants |
| V350+Car5 | Best Overall Response | No post-baseline tumour assessment | 33.3 Percentage of participants |
Secondary
Change From Baseline in Neutrophils
Change from baseline in neutrophils with the maximum value on treatment
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Change From Baseline in Neutrophils | 7.6 10^9 cells /L | Standard Deviation 7.3 |
| V100+Cis75 | Change From Baseline in Neutrophils | 3.3 10^9 cells /L | Standard Deviation 1.9 |
| V200+Cis75 | Change From Baseline in Neutrophils | 3.4 10^9 cells /L | Standard Deviation 2.3 |
| V300+Cis75 | Change From Baseline in Neutrophils | 3.0 10^9 cells /L | Standard Deviation 2.6 |
| V300+Cis100 | Change From Baseline in Neutrophils | 6.0 10^9 cells /L | Standard Deviation 4.3 |
| V350+Cis75 | Change From Baseline in Neutrophils | 5.2 10^9 cells /L | Standard Deviation 6.5 |
| V100+Car4 | Change From Baseline in Neutrophils | 2.1 10^9 cells /L | Standard Deviation 3.1 |
| V100+Car5 | Change From Baseline in Neutrophils | 6.8 10^9 cells /L | Standard Deviation 8.2 |
| V200+Car5 | Change From Baseline in Neutrophils | 3.6 10^9 cells /L | Standard Deviation 2.7 |
| V300+Car5 | Change From Baseline in Neutrophils | 5.9 10^9 cells /L | Standard Deviation 6.9 |
| V300+Car6 | Change From Baseline in Neutrophils | 5.5 10^9 cells /L | Standard Deviation 2.4 |
| V350+Car5 | Change From Baseline in Neutrophils | 4.7 10^9 cells /L | Standard Deviation 2.8 |
Secondary
Change From Baseline in Platelets
Change from baseline in platelets with the maximum value on treatment
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Change From Baseline in Platelets | 57 10^9 cells /L | Standard Deviation 48 |
| V100+Cis75 | Change From Baseline in Platelets | 65 10^9 cells /L | Standard Deviation 78 |
| V200+Cis75 | Change From Baseline in Platelets | 96 10^9 cells /L | Standard Deviation 94 |
| V300+Cis75 | Change From Baseline in Platelets | 71 10^9 cells /L | Standard Deviation 58 |
| V300+Cis100 | Change From Baseline in Platelets | 67 10^9 cells /L | Standard Deviation 58 |
| V350+Cis75 | Change From Baseline in Platelets | 89 10^9 cells /L | Standard Deviation 95 |
| V100+Car4 | Change From Baseline in Platelets | 186 10^9 cells /L | Standard Deviation 96 |
| V100+Car5 | Change From Baseline in Platelets | 50 10^9 cells /L | Standard Deviation 38 |
| V200+Car5 | Change From Baseline in Platelets | 49 10^9 cells /L | Standard Deviation 65 |
| V300+Car5 | Change From Baseline in Platelets | 39 10^9 cells /L | Standard Deviation 20 |
| V300+Car6 | Change From Baseline in Platelets | 73 10^9 cells /L | Standard Deviation 58 |
| V350+Car5 | Change From Baseline in Platelets | 104 10^9 cells /L | Standard Deviation 53 |
Secondary
Change From Baseline in Pulse Rate
Change from baseline in pulse rate at last value on treatment
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Change From Baseline in Pulse Rate | 10.0 bpm | Standard Deviation 10 |
| V100+Cis75 | Change From Baseline in Pulse Rate | 23.3 bpm | Standard Deviation 15.01 |
| V200+Cis75 | Change From Baseline in Pulse Rate | 6.7 bpm | Standard Deviation 17.24 |
| V300+Cis75 | Change From Baseline in Pulse Rate | -11.7 bpm | Standard Deviation 14.29 |
| V300+Cis100 | Change From Baseline in Pulse Rate | 10.3 bpm | Standard Deviation 14.35 |
| V350+Cis75 | Change From Baseline in Pulse Rate | 5.2 bpm | Standard Deviation 10.34 |
| V100+Car4 | Change From Baseline in Pulse Rate | 3.7 bpm | Standard Deviation 26.5 |
| V100+Car5 | Change From Baseline in Pulse Rate | 0.7 bpm | Standard Deviation 7.37 |
| V200+Car5 | Change From Baseline in Pulse Rate | 12.0 bpm | Standard Deviation 7.55 |
| V300+Car5 | Change From Baseline in Pulse Rate | 5.7 bpm | Standard Deviation 10.61 |
| V300+Car6 | Change From Baseline in Pulse Rate | 14.4 bpm | Standard Deviation 10.97 |
| V350+Car5 | Change From Baseline in Pulse Rate | -21.7 bpm | Standard Deviation 17.79 |
Secondary
Disease Control Rate
Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Disease Control Rate | 66.7 Percentage of participants |
| V100+Cis75 | Disease Control Rate | 100.0 Percentage of participants |
| V200+Cis75 | Disease Control Rate | 33.3 Percentage of participants |
| V300+Cis75 | Disease Control Rate | 66.7 Percentage of participants |
| V300+Cis100 | Disease Control Rate | 25.0 Percentage of participants |
| V350+Cis75 | Disease Control Rate | 33.3 Percentage of participants |
| V100+Car4 | Disease Control Rate | 33.3 Percentage of participants |
| V100+Car5 | Disease Control Rate | 33.3 Percentage of participants |
| V200+Car5 | Disease Control Rate | 0.0 Percentage of participants |
| V300+Car5 | Disease Control Rate | 50.0 Percentage of participants |
| V300+Car6 | Disease Control Rate | 15.4 Percentage of participants |
| V350+Car5 | Disease Control Rate | 33.3 Percentage of participants |
Secondary
Duration of Disease Control
Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set restricted to participants with confirmed disease control.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Duration of Disease Control | 196.5 Days | Standard Deviation 103.94 |
| V100+Cis75 | Duration of Disease Control | 309.0 Days | Standard Deviation 105.93 |
| V200+Cis75 | Duration of Disease Control | 264.0 Days | — |
| V300+Cis75 | Duration of Disease Control | 268.0 Days | Standard Deviation 237.59 |
| V300+Cis100 | Duration of Disease Control | 155.0 Days | Standard Deviation 49.36 |
| V350+Cis75 | Duration of Disease Control | 103.5 Days | Standard Deviation 9.19 |
| V100+Car4 | Duration of Disease Control | 135.0 Days | — |
| V100+Car5 | Duration of Disease Control | 229.0 Days | — |
| V300+Car5 | Duration of Disease Control | 234.0 Days | Standard Deviation 115.99 |
| V300+Car6 | Duration of Disease Control | 190.5 Days | Standard Deviation 74.25 |
| V350+Car5 | Duration of Disease Control | 126.0 Days | — |
Secondary
Duration of Objective Response
Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria. Tumour response was documented using appropriate techniques
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set restricted to participants with confirmed objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| V100+Cis75 | Duration of Objective Response | 298 Days |
| V300+Cis75 | Duration of Objective Response | 359 Days |
| V300+Car5 | Duration of Objective Response | 282 Days |
| V300+Car6 | Duration of Objective Response | 207 Days |
Secondary
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils \>=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 33.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 100.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 66.7 Percentage of participants |
| V300+Cis100 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 75.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 50.0 Percentage of participants |
| V100+Car4 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 33.3 Percentage of participants |
| V200+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 33.3 Percentage of participants |
| V300+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 83.3 Percentage of participants |
| V300+Car6 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 76.9 Percentage of participants |
| V350+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils | 100.0 Percentage of participants |
Secondary
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets \>=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 33.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 41.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 83.3 Percentage of participants |
| V100+Car4 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 33.3 Percentage of participants |
| V200+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 83.3 Percentage of participants |
| V300+Car6 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 76.9 Percentage of participants |
| V350+Car5 | Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets | 100.0 Percentage of participants |
Secondary
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment. Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 33.3 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 8.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 91.7 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 33.3 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 16.7 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 83.3 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 30.8 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 69.2 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=4 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
Secondary
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment. Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 66.7 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 100.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 33.3 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 33.3 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 16.7 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 16.7 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 8.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 33.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 25.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 16.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 16.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 16.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 16.7 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 16.7 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 16.7 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 50.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 16.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 7.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 53.8 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 7.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 15.4 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 15.4 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=1, worst value=3 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=0 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=4 | 33.3 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment | Baseline=0, worst value=3 | 66.7 Percentage of participants |
Secondary
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment. Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 16.7 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 83.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 66.7 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 33.3 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 83.3 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 16.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 84.6 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 7.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 7.7 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=0 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=3 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=0 | 100.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=0, last value=2 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment | Baseline=1, last value=1 | 0.0 Percentage of participants |
Secondary
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment. Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 33.3 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Cis60 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V100+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V200+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 66.7 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 8.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 25.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 33.3 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Cis100 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 16.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 16.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 66.7 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V350+Cis75 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 66.7 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V100+Car4 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 33.3 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V100+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 33.3 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 66.7 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V200+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 16.7 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 16.7 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 33.3 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V300+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 23.1 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 38.5 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 15.4 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 15.4 Percentage of participants |
| V300+Car6 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 7.7 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=4 | 66.7 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=2 | 33.3 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=3 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=0, worst value=0 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=1 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=0 | 0.0 Percentage of participants |
| V350+Car5 | Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment | Baseline=1, worst value=4 | 0.0 Percentage of participants |
Secondary
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V100+Cis60 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 100.0 Percentage of participants |
| V100+Cis60 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V100+Cis60 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V100+Cis60 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V100+Cis60 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V100+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V100+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 100.0 Percentage of participants |
| V100+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V100+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V100+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V200+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 66.7 Percentage of participants |
| V200+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 33.3 Percentage of participants |
| V200+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V200+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V200+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V300+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 0.0 Percentage of participants |
| V300+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V300+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V300+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 66.7 Percentage of participants |
| V300+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 33.3 Percentage of participants |
| V300+Cis100 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 8.3 Percentage of participants |
| V300+Cis100 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 41.7 Percentage of participants |
| V300+Cis100 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V300+Cis100 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 41.7 Percentage of participants |
| V300+Cis100 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 8.3 Percentage of participants |
| V350+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 50.0 Percentage of participants |
| V350+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V350+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 16.7 Percentage of participants |
| V350+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 33.3 Percentage of participants |
| V350+Cis75 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V100+Car4 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V100+Car4 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 33.3 Percentage of participants |
| V100+Car4 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V100+Car4 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 66.7 Percentage of participants |
| V100+Car4 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V100+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 66.7 Percentage of participants |
| V100+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V100+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V100+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 33.3 Percentage of participants |
| V100+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V200+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 66.7 Percentage of participants |
| V200+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V200+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 33.3 Percentage of participants |
| V200+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V200+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 0.0 Percentage of participants |
| V300+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V300+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 50.0 Percentage of participants |
| V300+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 50.0 Percentage of participants |
| V300+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V300+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V300+Car6 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 15.4 Percentage of participants |
| V300+Car6 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 61.5 Percentage of participants |
| V300+Car6 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V300+Car6 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V300+Car6 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 23.1 Percentage of participants |
| V350+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 2 | 0.0 Percentage of participants |
| V350+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 5 | 0.0 Percentage of participants |
| V350+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 1 | 0.0 Percentage of participants |
| V350+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 3 | 33.3 Percentage of participants |
| V350+Car5 | Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 | Grade 4 | 66.7 Percentage of participants |
Secondary
Objective Response Rate
Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0). Tumour response was documented using appropriate techniques
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Objective Response Rate | 0.0 Percentage of participants |
| V100+Cis75 | Objective Response Rate | 33.3 Percentage of participants |
| V200+Cis75 | Objective Response Rate | 0.0 Percentage of participants |
| V300+Cis75 | Objective Response Rate | 33.3 Percentage of participants |
| V300+Cis100 | Objective Response Rate | 0.0 Percentage of participants |
| V350+Cis75 | Objective Response Rate | 0.0 Percentage of participants |
| V100+Car4 | Objective Response Rate | 0.0 Percentage of participants |
| V100+Car5 | Objective Response Rate | 0.0 Percentage of participants |
| V200+Car5 | Objective Response Rate | 0.0 Percentage of participants |
| V300+Car5 | Objective Response Rate | 16.7 Percentage of participants |
| V300+Car6 | Objective Response Rate | 7.7 Percentage of participants |
| V350+Car5 | Objective Response Rate | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Dose Limiting Toxicities
Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.
Time frame: 3 weeks
Population: Treated set.~There was one patient in the V300+Car6 group whose DLT data was not evaluable, so only 12 patients had evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V100+Cis75 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V200+Cis75 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V300+Cis75 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V300+Cis100 | Percentage of Participants With Dose Limiting Toxicities | 25.0 Percentage of participants |
| V350+Cis75 | Percentage of Participants With Dose Limiting Toxicities | 33.3 Percentage of participants |
| V100+Car4 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V100+Car5 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V200+Car5 | Percentage of Participants With Dose Limiting Toxicities | 0.0 Percentage of participants |
| V300+Car5 | Percentage of Participants With Dose Limiting Toxicities | 16.7 Percentage of participants |
| V300+Car6 | Percentage of Participants With Dose Limiting Toxicities | 16.7 Percentage of participants |
| V350+Car5 | Percentage of Participants With Dose Limiting Toxicities | 66.7 Percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events
Percentage of participants with serious adverse events (AEs)
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Percentage of Participants With Serious Adverse Events | 66.7 Percentage of participants |
| V100+Cis75 | Percentage of Participants With Serious Adverse Events | 33.3 Percentage of participants |
| V200+Cis75 | Percentage of Participants With Serious Adverse Events | 0.0 Percentage of participants |
| V300+Cis75 | Percentage of Participants With Serious Adverse Events | 33.3 Percentage of participants |
| V300+Cis100 | Percentage of Participants With Serious Adverse Events | 50.0 Percentage of participants |
| V350+Cis75 | Percentage of Participants With Serious Adverse Events | 50.0 Percentage of participants |
| V100+Car4 | Percentage of Participants With Serious Adverse Events | 33.3 Percentage of participants |
| V100+Car5 | Percentage of Participants With Serious Adverse Events | 0.0 Percentage of participants |
| V200+Car5 | Percentage of Participants With Serious Adverse Events | 33.3 Percentage of participants |
| V300+Car5 | Percentage of Participants With Serious Adverse Events | 16.7 Percentage of participants |
| V300+Car6 | Percentage of Participants With Serious Adverse Events | 46.2 Percentage of participants |
| V350+Car5 | Percentage of Participants With Serious Adverse Events | 66.7 Percentage of participants |
Secondary
Percentage of Participants With Significant Adverse Events
Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE. DLTs (i.e. significant AEs) per protocol were: * drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity) * drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection * drug related CTCAE Grade 4 thrombocytopenia * drug related febrile neutropenia grade 3 (ANC\<1000/mm³ and fever≥ 38.5°C)
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V100+Cis75 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V200+Cis75 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V300+Cis75 | Percentage of Participants With Significant Adverse Events | 66.7 Percentage of participants |
| V300+Cis100 | Percentage of Participants With Significant Adverse Events | 25.0 Percentage of participants |
| V350+Cis75 | Percentage of Participants With Significant Adverse Events | 33.3 Percentage of participants |
| V100+Car4 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V100+Car5 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V200+Car5 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
| V300+Car5 | Percentage of Participants With Significant Adverse Events | 16.7 Percentage of participants |
| V300+Car6 | Percentage of Participants With Significant Adverse Events | 15.4 Percentage of participants |
| V350+Car5 | Percentage of Participants With Significant Adverse Events | 0.0 Percentage of participants |
Secondary
Progression-free Survival
Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| V100+Cis60 | Progression-free Survival | 123.0 Days |
| V100+Cis75 | Progression-free Survival | 309.0 Days |
| V200+Cis75 | Progression-free Survival | 37.0 Days |
| V300+Cis75 | Progression-free Survival | 100.0 Days |
| V300+Cis100 | Progression-free Survival | 49.5 Days |
| V350+Cis75 | Progression-free Survival | 69.5 Days |
| V100+Car4 | Progression-free Survival | 80.0 Days |
| V100+Car5 | Progression-free Survival | 64.0 Days |
| V200+Car5 | Progression-free Survival | 40.0 Days |
| V300+Car5 | Progression-free Survival | 71.0 Days |
| V300+Car6 | Progression-free Survival | 43.0 Days |
| V350+Car5 | Progression-free Survival | 39.0 Days |
Secondary
Total Plasma Clearance After Intravascular Administration (CL)
Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
Time frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Population: Pharmacokinetic (PK) set which included all participants in the treated set with evaluable PK data
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Total Plasma Clearance After Intravascular Administration (CL) | 852 mL/min | Geometric Coefficient of Variation 28.1 |
| V100+Cis75 | Total Plasma Clearance After Intravascular Administration (CL) | 1130 mL/min | Geometric Coefficient of Variation 28.1 |
| V200+Cis75 | Total Plasma Clearance After Intravascular Administration (CL) | 1090 mL/min | Geometric Coefficient of Variation 7.6 |
| V300+Cis75 | Total Plasma Clearance After Intravascular Administration (CL) | 1050 mL/min | Geometric Coefficient of Variation 22.7 |
| V300+Cis100 | Total Plasma Clearance After Intravascular Administration (CL) | 971 mL/min | Geometric Coefficient of Variation 28.6 |
| V350+Cis75 | Total Plasma Clearance After Intravascular Administration (CL) | 1010 mL/min | Geometric Coefficient of Variation 47.9 |
| V100+Car4 | Total Plasma Clearance After Intravascular Administration (CL) | 1110 mL/min | Geometric Coefficient of Variation 33.6 |
| V100+Car5 | Total Plasma Clearance After Intravascular Administration (CL) | 812 mL/min | Geometric Coefficient of Variation 11.7 |
| V200+Car5 | Total Plasma Clearance After Intravascular Administration (CL) | 881 mL/min | Geometric Coefficient of Variation 6.92 |
| V300+Car5 | Total Plasma Clearance After Intravascular Administration (CL) | 808 mL/min | Geometric Coefficient of Variation 20.7 |
| V300+Car6 | Total Plasma Clearance After Intravascular Administration (CL) | 974 mL/min | Geometric Coefficient of Variation 19.1 |
| V350+Car5 | Total Plasma Clearance After Intravascular Administration (CL) | 546 mL/min | Geometric Coefficient of Variation 16.7 |
Secondary
Worst CTCAE Grade on Treatment for Neutrophils
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V100+Cis60 | Worst CTCAE Grade on Treatment for Neutrophils | 2 Units on a scale |
| V100+Cis75 | Worst CTCAE Grade on Treatment for Neutrophils | 3 Units on a scale |
| V200+Cis75 | Worst CTCAE Grade on Treatment for Neutrophils | 0 Units on a scale |
| V300+Cis75 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
| V300+Cis100 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
| V350+Cis75 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
| V100+Car4 | Worst CTCAE Grade on Treatment for Neutrophils | 3 Units on a scale |
| V100+Car5 | Worst CTCAE Grade on Treatment for Neutrophils | 3 Units on a scale |
| V200+Car5 | Worst CTCAE Grade on Treatment for Neutrophils | 2 Units on a scale |
| V300+Car5 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
| V300+Car6 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
| V350+Car5 | Worst CTCAE Grade on Treatment for Neutrophils | 4 Units on a scale |
Secondary
Worst CTCAE Grade on Treatment for Platelets
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Population: Treated set
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| V100+Cis60 | Worst CTCAE Grade on Treatment for Platelets | 1 Units on a scale | 48 |
| V100+Cis75 | Worst CTCAE Grade on Treatment for Platelets | 1 Units on a scale | 78 |
| V200+Cis75 | Worst CTCAE Grade on Treatment for Platelets | 1 Units on a scale | 94 |
| V300+Cis75 | Worst CTCAE Grade on Treatment for Platelets | 2 Units on a scale | 58 |
| V300+Cis100 | Worst CTCAE Grade on Treatment for Platelets | 3 Units on a scale | 58 |
| V350+Cis75 | Worst CTCAE Grade on Treatment for Platelets | 3 Units on a scale | 95 |
| V100+Car4 | Worst CTCAE Grade on Treatment for Platelets | 1 Units on a scale | 96 |
| V100+Car5 | Worst CTCAE Grade on Treatment for Platelets | 3 Units on a scale | 38 |
| V200+Car5 | Worst CTCAE Grade on Treatment for Platelets | 1 Units on a scale | 65 |
| V300+Car5 | Worst CTCAE Grade on Treatment for Platelets | 4 Units on a scale | 20 |
| V300+Car6 | Worst CTCAE Grade on Treatment for Platelets | 4 Units on a scale | 58 |
| V350+Car5 | Worst CTCAE Grade on Treatment for Platelets | 4 Units on a scale | 53 |