Trial Outcomes & Findings for A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma (NCT NCT04154189)
NCT ID: NCT04154189
Last Updated: 2024-07-22
Results Overview
PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)
Results posted on
2024-07-22
Participant Flow
Participants took part in the study at 84 investigative sites in Austria, Australia, Belgium, Hong Kong, Korea, New Zealand, Singapore, Taiwan, Czech Republic, Finland, France, Israel, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, Canada, and the United States.
A total of 99 participants were screened, 18 failed screening. 81 participants were enrolled and randomized, out of which 78 received the study treatment.
Participant milestones
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Participants received lenvatinib 14 milligrams per square meter (mg/m\^2), capsules, orally, once daily, plus ifosfamide 3000 milligrams per square meter per day (mg/m\^2/day), intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until disease progression (PD), development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per response evaluation criteria in solid tumors (RECIST) version (v) 1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
Treated (Safety Analysis Set)
|
39
|
39
|
|
Overall Study
Optional Lenvatinib Treatment (Arm B Only)
|
0
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
41
|
Reasons for withdrawal
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Participants received lenvatinib 14 milligrams per square meter (mg/m\^2), capsules, orally, once daily, plus ifosfamide 3000 milligrams per square meter per day (mg/m\^2/day), intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until disease progression (PD), development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per response evaluation criteria in solid tumors (RECIST) version (v) 1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Survival follow-up discontinued by sponsor
|
8
|
10
|
|
Overall Study
Participants transitioned to patient access program (PAP)
|
1
|
0
|
|
Overall Study
Participants transitioned to managed access program (MAP)
|
2
|
0
|
|
Overall Study
Death
|
25
|
25
|
Baseline Characteristics
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
Baseline characteristics by cohort
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 3.76 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 4.16 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)Population: FAS included all randomized participants regardless of the treatment actually received.
PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment
|
6.5 months
Interval 5.7 to 8.2
|
5.5 months
Interval 2.9 to 6.5
|
SECONDARY outcome
Timeframe: Month 4Population: FAS included all randomized participants regardless of the treatment actually received.
PFS rate at 4 months as assessed by IIR was defined as the percentage of participants who were alive and without PD at 4 months from the randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. The PFS-4m was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Percentage of Participants With PFS at Month 4 (PFS-4m Rate) by IIR Assessment
|
76.3 percentage of participants
Interval 59.3 to 86.9
|
66.0 percentage of participants
Interval 47.7 to 79.2
|
SECONDARY outcome
Timeframe: Month 12 or 1 YearPopulation: FAS included all randomized participants regardless of the treatment actually received.
PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment
|
NA percentage of participants
Number and 95% confidence interval data could not be estimated because all participants had an event or were censored before Month 12.
|
14.9 percentage of participants
Interval 1.1 to 44.5
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death from any cause (up to 37.1 months)Population: FAS included all randomized participants regardless of the treatment actually received.
OS was defined as the time from the date of randomization to the date of death from any cause. The median OS was from Kaplan-Meier product-limit estimates and 2-sided 95% CIs from a generalized Brookmeyer and Crowley method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Overall Survival (OS)
|
12.4 months
Interval 10.4 to 19.8
|
17.2 months
Interval 11.1 to 22.3
|
SECONDARY outcome
Timeframe: Month 12 or 1 YearPopulation: FAS included all randomized participants regardless of the treatment actually received.
OS-1y was defined as the time from the date of randomization to the date of death from any cause assessed up to 1 year. OS was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Percentage of Participants With Overall Survival at 1 Year or Month 12 (OS-1y)
|
49.2 percentage of participants
Interval 28.5 to 67.0
|
72.1 percentage of participants
Interval 54.2 to 83.9
|
SECONDARY outcome
Timeframe: Month 4Population: FAS included all randomized participants regardless of the treatment actually received.
ORR-4m was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined by IIR using RECIST v1.1 within the first 4 months. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% confidence interval (CI) of ORR was calculated using the method of Clopper and Pearson.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Objective Response Rate at Month 4 (ORR-4m) by IIR Assessment
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of the first documentation of CR or PR (up to 20.5 months)Population: FAS included all randomized participants regardless of the treatment actually received.
ORR by IIR was defined as the percentage of participants with best overall response of CR or PR determined using RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% CI of ORR was calculated using the method of Clopper and Pearson.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=40 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=41 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
ORR by IIR Assessment
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
9.8 percentage of participants
Interval 2.7 to 23.1
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of study drug (up to 40.8 months)Population: Safety Analysis Set included participants who received at least 1 dose of any study drug.
TEAE was defined as an adverse event (AE) that emerged during time from first dose to 30 days following last dose of drug, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to pretreatment state, when AE was continuous. Serious adverse events (SAE) was defined as untoward medical occurrence that at any dose resulted in death; was life threatening; resulted in persistent or significant disability; was congenital anomaly or medically important due to other reasons than above mentioned criteria.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=39 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=39 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Participants with TEAEs
|
38 Participants
|
39 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Participants with TESAEs
|
30 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: Pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: Pre-dose (each Cycle length = 21 days)Population: Population Pharmacokinetic (PK) Analysis Set included those participants who received at least 1 dose of lenvatinib and had documented dose administration history and measurable plasma concentrations of lenvatinib. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
Plasma concentration of lenvatinib in participants from Treatment Arm A (Lenvatinib + Ifosfamide + Etoposide) at different time points were reported. As planned, data for this outcome measure was analyzed for treatment arm A only. Lenvatinib concentration in plasma was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=37 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 1, Day 15: 0.5-4 hours post-dose
|
222.3 nanograms per milliliter (ng/mL)
Standard Deviation 203.07
|
—
|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 1, Day 1: 0.5-4 hours post-dose
|
147.9 nanograms per milliliter (ng/mL)
Standard Deviation 194.61
|
—
|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 1, Day 1: 6-10 hours post-dose
|
217.8 nanograms per milliliter (ng/mL)
Standard Deviation 99.54
|
—
|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 1, Day 15: Pre-dose
|
70.7 nanograms per milliliter (ng/mL)
Standard Deviation 43.48
|
—
|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 1, Day 15: 6-10 hours post-dose
|
310.9 nanograms per milliliter (ng/mL)
Standard Deviation 106.79
|
—
|
|
Treatment Arm A: Plasma Concentration of Lenvatinib
Cycle 2, Day 1: Pre-dose
|
70.2 nanograms per milliliter (ng/mL)
Standard Deviation 67.95
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline patient-reported outcome (PRO) assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
Health-Related Quality of Life (HRQoL): PedsQL 4.0 Generic Core Scale is a multidimensional scale. It included assessment of 4 dimensions: physical functioning (8 items), emotional functioning (8 items), social functioning (8 items), and school functioning (5 items - children greater than or equal to \[\>=\] 5 years, adults; 3 items - toddlers \[aged 2-4 years\]). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Generic Core Scale total score: sum of all the items divided by the number of items answered across all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=15 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=4 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4
|
2.61 score on a scale
Standard Deviation 17.568
|
2.65 score on a scale
Standard Deviation 4.128
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline PRO assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers \[aged 2-4\], 4 items - young children \[aged 5-7\]; 5 items for children aged \>=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=16 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=4 Participants
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4
|
2.66 score on a scale
Standard Deviation 9.989
|
2.08 score on a scale
Standard Deviation 6.736
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Cycle length = 21 days)Population: Palatability and acceptability analysis set included all participants who received oral suspension of lenvatinib in Treatment Arm A and who received an optional lenvatinib suspension in Treatment Arm B and who answered at least 1 question in the palatability questionnaire. As planned, combined data for Lenvatinib from Treatment Arm A and B was reported for this outcome measure. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
The palatability and acceptability of lenvatinib oral suspension formulation was assessed using the Palatability Questionnaire. In the questionnaire, participants were asked to answer palatability and acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell, how does it feel in the mouth and overall acceptability in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. In this outcome measure, number of participants have been reported per their overall palatability and acceptability responses.
Outcome measures
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=5 Participants
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Super Bad
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Really Bad
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Bad
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
May be Good or May be Bad
|
2 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Good
|
2 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Really Good
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
Super Good
|
1 Participants
|
—
|
Adverse Events
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Serious events: 30 serious events
Other events: 38 other events
Deaths: 25 deaths
Treatment Arm B: Ifosfamide + Etoposide
Serious events: 20 serious events
Other events: 39 other events
Deaths: 25 deaths
Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)
Serious events: 10 serious events
Other events: 16 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=39 participants at risk
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=39 participants at risk
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)
n=16 participants at risk
Eligible participants from Treatment Arm B: Ifosfamide+Etoposide who had PD per RECIST v1.1 received an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|---|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Skin infection
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
38.5%
15/39 • Number of events 27 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
17.9%
7/39 • Number of events 10 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Anal fistula
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Catheter site ulcer
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Pyrexia
|
15.4%
6/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Cholecystitis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Hepatitis acute
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
COVID-19
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Device related infection
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Escherichia sepsis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Gastroenteritis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Infection
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Infectious pleural effusion
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Osteomyelitis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Pleural infection
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Pneumonia
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Pneumonia fungal
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Post procedural cellulitis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Platelet count decreased
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Transaminases increased
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
10.3%
4/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to heart
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Malignant spinal cord compression
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Seizure
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Toxic encephalopathy
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Product Issues
Device breakage
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Product Issues
Device extrusion
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Proteinuria
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Renal tubular injury
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
17.9%
7/39 • Number of events 12 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
25.0%
4/16 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Vascular disorders
Hypertensive urgency
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Oedema peripheral
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Pulmonary haemorrhage
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
Other adverse events
| Measure |
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
n=39 participants at risk
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
|
Treatment Arm B: Ifosfamide + Etoposide
n=39 participants at risk
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)
n=16 participants at risk
Eligible participants from Treatment Arm B: Ifosfamide+Etoposide who had PD per RECIST v1.1 received an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
4/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.8%
12/39 • Number of events 23 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
20.5%
8/39 • Number of events 19 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.8%
5/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.5%
8/39 • Number of events 13 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.8%
5/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Vascular disorders
Hypertension
|
41.0%
16/39 • Number of events 39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
37.5%
6/16 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Vascular disorders
Hypotension
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Anaemia
|
71.8%
28/39 • Number of events 180 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
69.2%
27/39 • Number of events 102 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 10 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.8%
5/39 • Number of events 53 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 27 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.6%
1/39 • Number of events 17 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 26 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
9/39 • Number of events 39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
23.1%
9/39 • Number of events 20 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
6/39 • Number of events 50 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 12 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Cardiac disorders
Tachycardia
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Endocrine disorders
Hypothyroidism
|
89.7%
35/39 • Number of events 52 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
50.0%
8/16 • Number of events 9 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Eye disorders
Eye pain
|
5.1%
2/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
7/39 • Number of events 18 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 12 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
4/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Constipation
|
35.9%
14/39 • Number of events 20 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
25.0%
4/16 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Diarrhoea
|
35.9%
14/39 • Number of events 20 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
25.0%
4/16 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Nausea
|
59.0%
23/39 • Number of events 56 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
41.0%
16/39 • Number of events 30 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
31.2%
5/16 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Proctalgia
|
7.7%
3/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Stomatitis
|
25.6%
10/39 • Number of events 14 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
15.4%
6/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Vomiting
|
48.7%
19/39 • Number of events 44 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
28.2%
11/39 • Number of events 17 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
31.2%
5/16 • Number of events 12 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Asthenia
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Face oedema
|
5.1%
2/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Fatigue
|
33.3%
13/39 • Number of events 28 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
23.1%
9/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
25.0%
4/16 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Generalised oedema
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Impaired healing
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Non-cardiac chest pain
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Oedema
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Pyrexia
|
30.8%
12/39 • Number of events 16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.7%
3/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
COVID-19
|
20.5%
8/39 • Number of events 9 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Catheter site infection
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Herpes zoster
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Rash pustular
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Rhinitis
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Wound infection
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
3/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Alanine aminotransferase increased
|
17.9%
7/39 • Number of events 27 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Amylase increased
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Aspartate aminotransferase increased
|
17.9%
7/39 • Number of events 25 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
3/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood bilirubin increased
|
7.7%
3/39 • Number of events 20 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood creatinine increased
|
15.4%
6/39 • Number of events 9 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
C-reactive protein increased
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Ejection fraction decreased
|
10.3%
4/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Electrocardiogram T wave abnormal
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.3%
4/39 • Number of events 18 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Lymphocyte count decreased
|
12.8%
5/39 • Number of events 28 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
17.9%
7/39 • Number of events 32 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Neutrophil count decreased
|
38.5%
15/39 • Number of events 79 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
33.3%
13/39 • Number of events 38 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Platelet count decreased
|
59.0%
23/39 • Number of events 209 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
43.6%
17/39 • Number of events 57 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 12 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Weight decreased
|
20.5%
8/39 • Number of events 13 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
31.2%
5/16 • Number of events 10 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Weight increased
|
5.1%
2/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
White blood cell count decreased
|
12.8%
5/39 • Number of events 38 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
33.3%
13/39 • Number of events 47 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.5%
8/39 • Number of events 10 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
31.2%
5/16 • Number of events 10 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
5.1%
2/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.3%
4/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.1%
2/39 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 9 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.8%
5/39 • Number of events 19 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
15.4%
6/39 • Number of events 13 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.4%
6/39 • Number of events 17 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.4%
6/39 • Number of events 26 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
17.9%
7/39 • Number of events 9 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.2%
11/39 • Number of events 24 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
15.4%
6/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
18.8%
3/16 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
38.5%
15/39 • Number of events 22 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
15.4%
6/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
25.0%
4/16 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
4/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.1%
2/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.8%
5/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
7/39 • Number of events 15 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.1%
9/39 • Number of events 14 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 5 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
37.5%
6/16 • Number of events 21 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • Number of events 8 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Headache
|
35.9%
14/39 • Number of events 20 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
15.4%
6/39 • Number of events 6 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
31.2%
5/16 • Number of events 28 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Toxic encephalopathy
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Tremor
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Psychiatric disorders
Anxiety
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Psychiatric disorders
Depression
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Psychiatric disorders
Insomnia
|
7.7%
3/39 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 4 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Dysuria
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Glycosuria
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
10.3%
4/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Haematuria
|
10.3%
4/39 • Number of events 11 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
3/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Renal and urinary disorders
Proteinuria
|
53.8%
21/39 • Number of events 79 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
37.5%
6/16 • Number of events 21 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
7/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.8%
5/39 • Number of events 7 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Early satiety
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Infusion site bruising
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Infusion site swelling
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
General disorders
Oedema peripheral
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Blood pressure increased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Haemoglobin increased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Investigations
Lipase increased
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
12.5%
2/16 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Nervous system disorders
Migraine
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Eye disorders
Dry eye
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Overgrowth bacterial
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Infections and infestations
Paronychia
|
5.1%
2/39 • Number of events 3 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
2/39 • Number of events 2 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
2.6%
1/39 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/16 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
0.00%
0/39 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
6.2%
1/16 • Number of events 1 • From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place