Trial Outcomes & Findings for Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma (NCT NCT01399372)
NCT ID: NCT01399372
Last Updated: 2023-07-20
Results Overview
Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.
Results posted on
2023-07-20
Participant Flow
Participant milestones
| Measure |
Chemotherapy
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
44
|
|
Overall Study
Eligible
|
44
|
43
|
|
Overall Study
Eligible and Started Protocol Treatment
|
43
|
43
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Chemotherapy
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=44 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
59.5 years
n=5 Participants
|
66 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
30-50
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
60-80
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
90-100
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Neurologic Symptoms
None
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Neurologic Symptoms
Minor
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Neurologic Symptoms
Moderate
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Neurologic Symptoms
Severe
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Recursive Partitioning analysis (RPA) Class
Class 1
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Recursive Partitioning analysis (RPA) Class
Class 2
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Recursive Partitioning analysis (RPA) Class
Class 3
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ocular Involvement
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cerebrospinal fluid (CSF) Involvement
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.Population: Eligible participants
Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Chemotherapy
n=44 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Progression-free Survival
|
2.1 years
Interval 1.0 to
There were not enough events to estimate the upper confidence boundary.
|
NA years
Interval 3.3 to
The median has not yet been reached. Additionally there were not enough events to estimate the upper confidence boundary.
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.Population: Eligible participants
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Chemotherapy
n=44 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Overall Survival
|
NA years
Interval 2.6 to
The median has not yet been reached. Additionally there were not enough events to estimate the upper confidence boundary.
|
NA years
Interval 4.5 to
The median has not yet been reached. Additionally there were not enough events to estimate the upper confidence boundary.
|
SECONDARY outcome
Timeframe: After 4th cycle of chemotherapy, approximately 4 months after randomization.Population: Eligible participants with Cycle 4 disease assessment data
Response was evaluated using the international criteria proposed by the International Primary Central Nervous System Lymphoma (PCNSL) Study Group criteria. Complete Response was defined as no contrast brain enhancement on magnetic resonance imaging (MRI), no corticosteroid use for at least 2 weeks, a normal eye exam, and negative CSF cytology. Partial response was defined as at least 50% decrease in enhancing tumor on MRI compared with baseline imaging, no or minor retinal pigment epithelium (RPE) abnormality, and negative CSF cytology.
Outcome measures
| Measure |
Chemotherapy
n=30 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=31 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Percentage of Participants Experiencing Partial Response or Complete Response
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
SECONDARY outcome
Timeframe: EORTC QLQ-C30 was administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years.Population: Eligible, consented to quality of life study component, and has GHS score for at least one timepoint.
Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Data through five years after end of protocol treatment is included in the analysis, while summary data is provided only through three years due to very few participants after that timepoint.
Outcome measures
| Measure |
Chemotherapy
n=34 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=35 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
End of cycle 4
|
67.67 score on a scale
Standard Deviation 23.97
|
64.58 score on a scale
Standard Deviation 20.49
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
6 Months Post-Treatment
|
74.54 score on a scale
Standard Deviation 20.70
|
75.35 score on a scale
Standard Deviation 20.48
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Baseline
|
62.78 score on a scale
Standard Deviation 23.54
|
54.90 score on a scale
Standard Deviation 26.91
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
12 Months Post-Treatment
|
78.47 score on a scale
Standard Deviation 22.88
|
78.99 score on a scale
Standard Deviation 24.73
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
18 Months Post-Treatment
|
76.79 score on a scale
Standard Deviation 20.46
|
76.67 score on a scale
Standard Deviation 24.27
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
24 Months Post-Treatment
|
70.83 score on a scale
Standard Deviation 25.00
|
83.33 score on a scale
Standard Deviation 21.43
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
30 Months Post-Treatment
|
77.08 score on a scale
Standard Deviation 24.13
|
79.63 score on a scale
Standard Deviation 17.90
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
36 Months Post-Treatment
|
75.00 score on a scale
Standard Deviation 27.78
|
85.00 score on a scale
Standard Deviation 13.80
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
42 Months Post-Treatment
|
75.00 score on a scale
Standard Deviation 21.52
|
77.56 score on a scale
Standard Deviation 19.95
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
48 Months Post-Treatment
|
79.76 score on a scale
Standard Deviation 21.97
|
84.38 score on a scale
Standard Deviation 19.64
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
54 Months Post-Treatment
|
70.24 score on a scale
Standard Deviation 16.67
|
91.67 score on a scale
Standard Deviation 10.21
|
|
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
60 Months Post-Treatment
|
80.56 score on a scale
Standard Deviation 17.35
|
83.33 score on a scale
Standard Deviation NA
Standard deviation cannot be computed if there is only one observation, as in this case.
|
SECONDARY outcome
Timeframe: Neurocognitive function tests were administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years. Two-year rates are provided here.Population: Eligible, consented to neurocognitive function study component and has at least two completed neurocognitive tests at baseline and at least one post baseline visit.
Neurocognitive failure is defined as cognitive failure on two or more of the following tests: Hopkins Verbal Learning Test - Revised (HVLT-R) Free Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test Part A, Trail Making Test Part B, and Controlled Oral Word Association. Cognitive failure for each test is defined as a change from baseline in raw score (post baseline score - baseline score) at or exceeding the minimally important difference reported in the literature \[determined by the reliable change index (RCI) method\] of -5, -3, -2,12, 26, and -12, respectively, indicating a worsening of neurocognitive function. Time to neurocognitive failure is defined as time from randomization to date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method and the distributions of failure times are compared between the arms. Two-year estimates are provided here.
Outcome measures
| Measure |
Chemotherapy
n=30 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=32 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Percentage of Participants With Neurocognitive Failure
|
31.6 percentage of participants
Interval 14.3 to 50.5
|
17.9 percentage of participants
Interval 6.3 to 34.1
|
SECONDARY outcome
Timeframe: At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 7.3 years.Population: Eligible participants who started protocol treatment
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events reported as definitely, probably, or possibly related to protocol treatment are considered to be related to treatment.
Outcome measures
| Measure |
Chemotherapy
n=43 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 Participants
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
None
|
2 Participants
|
3 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
Grade 1
|
3 Participants
|
6 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
Grade 2
|
4 Participants
|
5 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
Grade 3
|
20 Participants
|
15 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
Grade 4
|
14 Participants
|
13 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
Grade 5
|
0 Participants
|
1 Participants
|
Adverse Events
Chemotherapy
Serious events: 22 serious events
Other events: 42 other events
Deaths: 3 deaths
Chemotherapy + Low-Dose WBRT
Serious events: 21 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Chemotherapy
n=43 participants at risk
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 participants at risk
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Cardiac disorders
Heart failure
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Death NOS
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Fatigue
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Fever
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Hypothermia
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Appendicitis perforated
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Lung infection
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Sepsis
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Skin infection
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Investigations - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Hydrocephalus
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Seizure
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Syncope
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Vascular disorders
Hypotension
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
Other adverse events
| Measure |
Chemotherapy
n=43 participants at risk
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
Chemotherapy + Low-Dose WBRT
n=43 participants at risk
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
79.1%
34/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
69.8%
30/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Eye disorders
Blurred vision
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Eye disorders
Eye disorders - Other
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
48.8%
21/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
48.8%
21/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.5%
23/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
34.9%
15/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Chills
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Edema limbs
|
27.9%
12/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Fatigue
|
72.1%
31/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
88.4%
38/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Fever
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Gait disturbance
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Infusion related reaction
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
General disorders
Pain
|
23.3%
10/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Mucosal infection
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Skin infection
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
65.1%
28/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
58.1%
25/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
37.2%
16/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
46.5%
20/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
58.1%
25/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
51.2%
22/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Creatinine increased
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
34.9%
15/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Investigations - Other
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
46.5%
20/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
51.2%
22/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
46.5%
20/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
62.8%
27/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
60.5%
26/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Weight gain
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
Weight loss
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
51.2%
22/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
51.2%
22/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.9%
12/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
34.9%
15/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
32.6%
14/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
46.5%
20/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
30.2%
13/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.6%
11/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Ataxia
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dysarthria
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
37.2%
16/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
44.2%
19/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Memory impairment
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Paresthesia
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
39.5%
17/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
30.2%
13/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Nervous system disorders
Seizure
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Agitation
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
25.6%
11/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
25.6%
11/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Depression
|
18.6%
8/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
30.2%
13/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
23.3%
10/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Hematuria
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Urinary retention
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
20.9%
9/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
6/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
23.3%
10/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
11.6%
5/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Vascular disorders
Hypertension
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
9.3%
4/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Vascular disorders
Hypotension
|
7.0%
3/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
2.3%
1/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
16.3%
7/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
4.7%
2/43 • At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
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