Trial Outcomes & Findings for Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery (NCT NCT01989572)
NCT ID: NCT01989572
Last Updated: 2020-07-07
Results Overview
Overall survival is defined as time from randomization to death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
815 participants
Primary outcome timeframe
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Results posted on
2020-07-07
Participant Flow
The study was open between December 29, 1999 and October 31, 2006. A total of 815 patients were enrolled.
Participant milestones
| Measure |
Arm I (GM-CSF, Peptide Vaccine)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC
|
Arm II (GM-CSF Placebo, Peptide Vaccine)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
111
|
109
|
107
|
190
|
189
|
|
Overall Study
Treated
|
104
|
110
|
107
|
104
|
186
|
171
|
|
Overall Study
COMPLETED
|
54
|
53
|
47
|
56
|
92
|
79
|
|
Overall Study
NOT COMPLETED
|
55
|
58
|
62
|
51
|
98
|
110
|
Reasons for withdrawal
| Measure |
Arm I (GM-CSF, Peptide Vaccine)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC
|
Arm II (GM-CSF Placebo, Peptide Vaccine)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
35
|
48
|
48
|
43
|
71
|
79
|
|
Overall Study
Adverse Event
|
2
|
1
|
3
|
0
|
3
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
5
|
1
|
12
|
4
|
|
Overall Study
complicating disease
|
1
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
error
|
2
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
maximum dose reached
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
unknown/not specify
|
3
|
4
|
1
|
3
|
3
|
5
|
|
Overall Study
not start protocol therapy
|
5
|
1
|
2
|
3
|
4
|
18
|
|
Overall Study
alternative therapy
|
3
|
0
|
0
|
0
|
1
|
3
|
Baseline Characteristics
Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
Baseline characteristics by cohort
| Measure |
Arm I (GM-CSF, Peptide Vaccine)
n=109 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC
|
Arm II (GM-CSF Placebo, Peptide Vaccine)
n=111 Participants
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC
|
Arm III (GM-CSF, Peptide Placebo)
n=109 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
n=107 Participants
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
n=190 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
n=189 Participants
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
Total
n=815 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
58 years
n=4 Participants
|
60 years
n=21 Participants
|
57 years
n=10 Participants
|
58 years
n=115 Participants
|
|
Sex/Gender, Customized
Female
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
45 participants
n=5 Participants
|
39 participants
n=4 Participants
|
77 participants
n=21 Participants
|
77 participants
n=10 Participants
|
331 participants
n=115 Participants
|
|
Sex/Gender, Customized
Male
|
61 participants
n=5 Participants
|
66 participants
n=7 Participants
|
64 participants
n=5 Participants
|
68 participants
n=4 Participants
|
112 participants
n=21 Participants
|
112 participants
n=10 Participants
|
483 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15Population: all randomized patients, regardless of eligibility
Overall survival is defined as time from randomization to death from any cause.
Outcome measures
| Measure |
GM-CSF
n=408 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=407 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
69.6 months
Interval 53.4 to 83.5
|
59.3 months
Interval 44.4 to 77.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15Population: all randomized patients, regardless of eligibility
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Outcome measures
| Measure |
GM-CSF
n=408 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=407 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Recurrence Free Survival
|
11.4 months
Interval 9.4 to 14.8
|
8.8 months
Interval 7.5 to 11.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15Population: all HLA-A2 positive patients
Overall survival is defined as time from randomization to death from any cause.
Outcome measures
| Measure |
GM-CSF
n=220 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=216 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients
|
68.6 months
Interval 47.0 to 92.3
|
63.3 months
Interval 49.2 to 105.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15Population: all HLA-A2 positive patients
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Outcome measures
| Measure |
GM-CSF
n=220 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=216 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Recurrence Free Survival in HLA-A2 Positive Patients
|
11.5 months
Interval 8.7 to 20.4
|
9.8 months
Interval 7.7 to 15.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15Population: all randomized patients, regardless of eligibility
Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.
Outcome measures
| Measure |
GM-CSF
n=109 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=111 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
n=109 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
n=107 Participants
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
n=190 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
n=189 Participants
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
5-year Overall Survival Rate
|
55.5 percentage of participants
Interval 45.4 to 64.5
|
51.9 percentage of participants
Interval 42.0 to 61.0
|
51.1 percentage of participants
Interval 41.2 to 60.1
|
51.6 percentage of participants
Interval 41.4 to 60.9
|
51.2 percentage of participants
Interval 43.8 to 58.2
|
46.7 percentage of participants
Interval 39.3 to 53.8
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15Population: all randomized patients, regardless of eligibility
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Outcome measures
| Measure |
GM-CSF
n=109 Participants
Patients received GM-CSF in the trial, including patients on arms I, III, V.
|
GM-CSF Placebo
n=111 Participants
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
|
Arm III (GM-CSF, Peptide Placebo)
n=109 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
n=107 Participants
Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC
|
Arm V (GM-CSF)
n=190 Participants
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
n=189 Participants
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
5-year Recurrence Free Survival Rate
|
32.4 percentage of participants
Interval 23.6 to 41.5
|
33.2 percentage of participants
Interval 24.4 to 42.2
|
31.3 percentage of participants
Interval 22.8 to 40.2
|
28.0 percentage of participants
Interval 19.7 to 36.9
|
30.6 percentage of participants
Interval 24.1 to 37.3
|
22.9 percentage of participants
Interval 17.1 to 29.2
|
Adverse Events
Arm I (GM-CSF, Peptide Vaccine)
Serious events: 12 serious events
Other events: 104 other events
Deaths: 0 deaths
Arm II (GM-CSF Placebo, Peptide Vaccine)
Serious events: 17 serious events
Other events: 109 other events
Deaths: 0 deaths
Arm III (GM-CSF, Peptide Placebo)
Serious events: 15 serious events
Other events: 105 other events
Deaths: 0 deaths
Arm IV (GM-CSF Placebo, Peptide Placebo)
Serious events: 9 serious events
Other events: 102 other events
Deaths: 0 deaths
Arm V (GM-CSF)
Serious events: 22 serious events
Other events: 180 other events
Deaths: 0 deaths
Arm VI (GM-CSF Placebo)
Serious events: 12 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (GM-CSF, Peptide Vaccine)
n=104 participants at risk
Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide vaccine: Given SC
|
Arm II (GM-CSF Placebo, Peptide Vaccine)
n=110 participants at risk
Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC GM-CSF placebo: Given SC
|
Arm III (GM-CSF, Peptide Placebo)
n=107 participants at risk
Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
n=104 participants at risk
Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC peptide placebo: Given SC
|
Arm V (GM-CSF)
n=186 participants at risk
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
n=171 participants at risk
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Investigations
Creatinine increased
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Immune system disorders
Anaphylaxis
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
White blood cell decreased
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
2/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.1%
2/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.2%
2/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Cardiac disorders
Myocardial infarction
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Vascular disorders
Thromboembolic event
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Fatigue
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.8%
3/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Weight gain
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Weight loss
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Injection site reaction
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.2%
9/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.1%
2/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.1%
2/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.2%
2/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Infections and infestations
Infections and infestations - Other, spe
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue di
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specif
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Syncope
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.7%
4/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.1%
2/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Headache
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.2%
6/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
2/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Pain
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.93%
1/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.54%
1/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.6%
3/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Immune system disorders
Flushing
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
Other adverse events
| Measure |
Arm I (GM-CSF, Peptide Vaccine)
n=104 participants at risk
Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide vaccine: Given SC
|
Arm II (GM-CSF Placebo, Peptide Vaccine)
n=110 participants at risk
Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC GM-CSF placebo: Given SC
|
Arm III (GM-CSF, Peptide Placebo)
n=107 participants at risk
Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide placebo: Given SC
|
Arm IV (GM-CSF Placebo, Peptide Placebo)
n=104 participants at risk
Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC peptide placebo: Given SC
|
Arm V (GM-CSF)
n=186 participants at risk
Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC
|
Arm VI (GM-CSF Placebo)
n=171 participants at risk
Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
26.9%
28/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
21.8%
24/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
20.6%
22/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
20.2%
21/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
22.6%
42/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
21.1%
36/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
20.2%
21/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
13.6%
15/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
24.3%
26/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
17.3%
18/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
13.4%
25/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.4%
16/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
White blood cell decreased
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.2%
9/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.5%
8/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.5%
12/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.8%
7/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.6%
13/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Neutrophil count decreased
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.1%
10/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.6%
10/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.3%
8/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.4%
11/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Platelet count decreased
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.5%
8/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.7%
5/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.5%
6/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.4%
9/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.2%
6/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
5/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Fatigue
|
64.4%
67/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
48.2%
53/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
54.2%
58/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
54.8%
57/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
43.5%
81/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
38.6%
66/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Fever
|
16.3%
17/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
17.3%
19/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.0%
15/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.3%
21/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.6%
13/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Chills
|
23.1%
24/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.8%
13/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
13.1%
14/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
12.9%
24/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.0%
12/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
4/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.7%
4/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.9%
11/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.1%
7/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Weight gain
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.5%
6/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.6%
10/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.8%
7/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
8/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Weight loss
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.4%
7/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.3%
8/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
8/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
General disorders and administration sit
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.5%
6/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.3%
8/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
5/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.96%
1/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.6%
3/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.3%
4/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Injection site reaction
|
95.2%
99/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
90.9%
100/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
91.6%
98/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
85.6%
89/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
79.0%
147/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
25.1%
43/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
8/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.1%
10/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.0%
15/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.1%
17/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
5/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.0%
27/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
20.0%
22/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
30.8%
33/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
12.5%
13/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
16.7%
31/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.9%
17/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -
|
14.4%
15/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.5%
16/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
10.3%
11/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
13.5%
14/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.8%
22/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.5%
6/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Vascular disorders
Hot flashes
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
3/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.4%
7/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.1%
17/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.3%
9/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
24/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
21.8%
24/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
19.6%
21/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.4%
15/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
19.4%
36/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.1%
19/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Dysgeusia
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
2/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.8%
4/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.3%
4/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.5%
5/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.8%
4/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.3%
8/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
3/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
16/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.3%
8/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
10.3%
11/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
10.6%
11/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.5%
27/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
11.1%
19/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.5%
5/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.8%
3/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.6%
10/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
9/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.8%
15/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Blood bilirubin increased
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.4%
9/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
9/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
8/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.5%
12/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
12.7%
14/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
18.7%
20/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
14.4%
15/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
12.9%
24/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
10.5%
18/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.4%
7/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.5%
14/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.0%
12/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Dizziness
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.7%
4/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.8%
7/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
8/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
2/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
9/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.3%
9/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Psychiatric disorders
Anxiety
|
1.9%
2/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.3%
8/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.2%
2/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Psychiatric disorders
Depression
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.7%
3/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.9%
2/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
6/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.3%
4/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
4/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.6%
4/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.6%
6/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
12.5%
13/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.1%
7/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
1.8%
2/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.8%
3/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.9%
3/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.9%
11/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
3.5%
6/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.2%
20/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
20.9%
23/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
29.9%
32/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
17.3%
18/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
19.9%
37/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
15.8%
27/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.6%
10/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
10.0%
11/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
13.1%
14/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.7%
7/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.1%
15/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.8%
10/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.91%
1/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
2.8%
3/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.00%
0/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
0.58%
1/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.0%
25/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
29.1%
32/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
35.5%
38/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
24.0%
25/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
30.6%
57/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
15.2%
26/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
General disorders
Pain
|
7.7%
8/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
8.2%
9/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
9.6%
10/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
6.4%
11/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
|
Investigations
Creatinine increased
|
4.8%
5/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.5%
6/110 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
5/107 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
7.7%
8/104 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
5.4%
10/186 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
4.7%
8/171 • Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is \<2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if \>5 years.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60